natgillin/translations-raw huggingface dataset:
It is unknown whether dolutegravir or rilpivirine are excreted in human milk.
Ni znano, če se dolutegravir ali rilpivirin pri človeku izločata v materino mleko.
Rilpivirine demonstrated limited in vitro activity against HIV-2 with IC50 values ranging from 2,510 to 10,830 nM.
Aktivnost rilpivirina in vitro proti HIV-2 je bila omejena, z vrednostmi IC50 od 2.510 do 10.830 nM.
(reduced absorption due to gastric pH increase).
(zmanjšana absorpcija zaradi zvišanja pH v želodcu).
Juluca contains dolutegravir.
Zdravilo Juluca vsebuje dolutegravir.
• 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).
• zdravila, imenovana antagonisti receptorjev H2 (na primer cimetidin, famotidin, nizatidin, ranitidin), za zdravljenje razjed v želodcu ali črevesu ali za ublažitev zgage zaradi refluksa kisline.
Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
Nekaterim osebam, ki jemljejo zdravila za zdravljenje okužbe z virusom HIV, se pojavijo druge zdravstvene težave, ki so lahko resne.
If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Če je do naslednjega odmerka preostalo manj kot 12 ur, bolnik ne sme vzeti pozabljenega odmerka, ampak mora nadaljevati jemanje po rednem urniku.
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.
Vpliva hude okvare jeter (Child-Pugh C) na farmakokinetiko dolutegravirja ali rilpivirina niso raziskali, zato zdravila Juluca pri teh bolnikih ni priporočljivo uporabljati.
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).
Zdravilo Juluca je indicirano za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki imajo virološko supresijo (HIV-1 RNA < 50 kopij/ml) ob že vsaj šest mesecev trajajočem zdravljenju s stabilno protiretrovirusno shemo, v anamnezi nimajo virološkega neuspeha ter nimajo znane ali domnevne odpornosti na katerikoli nenukleozidni zaviralec reverzne transkriptaze ali zaviralec integraze (glejte poglavje 5.1).
Gastrointestinal disorders very common nausea increased pancreatic amylase diarrhoea common abdominal pain vomiting flatulence increased lipase abdominal discomfort upper abdominal pain dry mouth
Bolezni prebavil zelo pogosti navzea zvišanje pankreatične amilaze driska pogosti bolečine v trebuhu bruhanje flatulenca zvišanje lipaze nelagodje v trebuhu bolečine v zgornjem delu trebuha suha usta
The use of Juluca during pregnancy is not recommended.
Uporaba zdravila Juluca med nosečnostjo ni priporočljiva.
In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
In vivo so pri bolnikih opažali od 10-14 % zmanjšanje očistka kreatinina (sekrecijska frakcija je odvisna od prenosa z OCT2 in MATE-1).
The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Vpliv mutacij Q148 (H/R/K) se je skladal tudi z in vitro poskusi prehoda s točkovnimi mutanti.
The safety and efficacy of Juluca in pregnancy have not yet been established.
Nosečnost Varnost in učinkovitost zdravila Juluca v nosečnosti še nista ugotovljeni.
The Juluca tablet must be taken with a meal.
Tableto zdravila Juluca je treba vzeti z obrokom.
Juluca should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Zdravljenje z zdravilom Juluca je treba takoj prekiniti, če se pojavijo znaki ali simptomi preobčutljivostnih reakcij (na primer hud izpuščaj ali izpuščaj s sočasnim zvišanjem jetrnih encimov, zvišana telesna temperatura, splošno slabo počutje, utrujenost, bolečine v mišicah ali sklepih, mehurji, lezije v ustih, konjunktivitis, edem obraza, eozinofilija, angioedem ali drugi).
AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
AUC v semenu je bila 7 % in v tkivu danke 17 % AUC v plazmi v stanju dinamičnega ravnovesja.
A risk for increases in dabigatran plasma concentrations cannot be excluded
Dabigatran eteksilat ↑ Tveganja za povišanje koncentracije dabigatrana v plazmi ni mogoče izključiti.
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 spada v skupino protiretrovirusnih zdravil, ki jih imenujemo zaviralci integraze (INI), rilpivirin pa spada v skupino protiretrovirusnih zdravil, ki jih imenujemo nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
Rilpivirine studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Rilpivirin v študijah na živalih ni pokazal pomembnih embrio- ali fetotoksičnih učinkov ali učinkov na sposobnost razmnoževanja.
Do not take Juluca: - if you are allergic to dolutegravir or rilpivirine or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na dolutegravir ali rilpivirin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Juluca must not be taken with some other medicines (see ‘Do not take Juluca' earlier in section 2).
Zdravila Juluca ne smete jemati z nekaterimi drugimi zdravili (glejte "Ne jemljite zdravila Juluca", zgoraj v poglavju 2).
In a Week 96 pooled analyses of virologic failures with baseline viral load ≤100,000 copies/mL and resistance to rilpivirine (n = 5), subjects had cross-resistance to efavirenz (n = 3), etravirine (n = 4), and nevirapine (n = 1).
V kumulativni analizi viroloških neuspehov po 96 tednih v primerih z izhodiščnim virusnim bremenom ≤ 100.000 kopij/ml in odpornostjo proti rilpivirinu (n = 5) so ugotovili navzkrižno odpornost proti efavirenzu (n = 3), etravirinu (n = 4) in nevirapinu (n = 1).
Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Pri nekaterih bolniki, ki prejemajo kombinirano zdravljenje okužbe z virusom HIV, se lahko razvije motnja, imenovana osteonekroza.
Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Sočasna uporaba dolutegravirja in dofetilida je kontraindicirana zaradi možne smrtno nevarne toksičnosti, ki jo povzroča visoka koncentracija dofetilida (glejte poglavje 4.3).
• artemether/lumefantrine used to prevent you catching malaria
• kombinacijo artemeter/lumefantrin, ki se uporablja za preprečevanje malarije,
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.
V študiji C213 telesna masa pri pediatričnih preiskovancih (od 33 do 93 kg) ni vplivala na farmakokinetiko rilpivirina; to je podobno, kot so opažali pri odraslih.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 90 (3 pakiranja po 30) tablet.
Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Dolutegravir se po peroralni uporabi hitro absorbira; med uporabo tablet je mediani tmax od 2 do 3 ure po odmerku.
Hepatobiliary disorders very common increased transaminases (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations)
Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje transaminaz (zvišanje alanin-aminotransferaze (ALT) in/ali aspartat-aminotransferaze (AST))
In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1).
In vitro je dolutegravir zaviral ledvični prenašalec organskih kationov 2 (OCT2) in prenašalec za ekstruzijo več zdravil in toksinov 1 (MATE-1).
Dexamethasone/ Rilpivirine (systemic, except for single dose use)
deksametazon/ dolutegravir deksametazon/ rilpivirin (sistemska uporaba, razen pri uporabi enkratnega odmerka)
What Juluca looks like and contents of the pack
Izgled zdravila Juluca in vsebina pakiranja
- 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).
- Druge sestavine zdravila so manitol (E421), magnezijev stearat, mikrokristalna celuloza, povidon (K29/32), natrijev karboksimetilškrob, natrijev stearilfumarat, laktoza monohidrat, premreženi natrijev karmelozat, povidon (K30), polisorbat 20, silicificirana mikrokristalna celuloza, delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol, smukec, rumeni železov oksid (E172), rdeči železov oksid (E172).
• increase in the level of enzymes produced in the muscles (creatine phosphokinase).
• zvišanje ravni encima, ki nastaja v mišicah (kreatin-fosfokinaza),
• stomach (abdominal) pain or discomfort
• bolečine v trebuhu (abdominalne) ali nelagodje v želodcu,
In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with dolutegravir, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
Pri bolnikih z zmerno okvaro ledvic je treba v primeru sočasne uporabe z dolutegravirjem razmisliti o prilagoditvi odmerka metformina, ker imajo ti bolniki zaradi večje koncentracije metformina večje tveganje za laktacidozo (glejte poglavje 4.4).
NA = Not applicable
NP = ni potrebno
No efficacy and safety data are available for the combination of dolutegravir and rilpivirine in pregnancy.
Nosečnost: Podatkov o učinkovitosti in varnosti kombinacije dolutegravirja in rilpivirina med nosečnostjo ni.
Joint pain, stiffness and bone problems
Bolečine v sklepih, okorelost in težave s kostmi
Rilpivirine is primarily metabolised by CYP3A.
Rilpivirin se primarno presnavlja s CYP3A.
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.
Med proučevanjem supraterapevtskih odmerkov rilpivirina 75 mg enkrat na dan oziroma 300 mg enkrat na dan pri zdravih odraslih sta bili največji povprečni za čas usklajeni (zgornja meja 95 % intervala zaupanja) razliki intervala QTcF v primerjavi s placebom in po korekciji za izhodiščno vrednost 10,7 (15,3) oziroma 23,3 (28,4) ms.
If you take more Juluca than you should
Če ste vzeli večji odmerek zdravila Juluca kot bi smeli
Resistance to rilpivirine was considered present when FC in EC50 value was above the biological cut-off (BCO) of the assay.
Veljalo je, da je odpornost proti rilpivirinu prisotna, če sta bila FC in EC50 nad biološko presečno mejo (BCO - biological cut-off) preizkusa.
Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption due to gastric pH increase).
Pričakovano je pomembno zmanjšanje koncentracije rilpivirina v plazmi (zmanjšana absorpcija zaradi zvišanja pH v želodcu).
CAR N=511 n (%)
Trenutna protiretrovirusna shema N = 511 n (%)
In lactating rats that received a single oral dose of dolutegravir 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Pri doječih podganah, ki so 10. dan po kotitvi dobile enkraten peroralni odmerek dolutegravirja 50 mg/kg, je bila koncentracija dolutegravirja v mleku praviloma večja kot v krvi.
Dolutegravir had a <10 FC against 94% of the 705 clinical isolates.
Dolutegravir je imel proti 94 % od teh 705 kliničnih izolatov FC < 10.
Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Farmakokinetika dolutegravirja je pri zdravih osebah in osebah, okuženih z virusom HIV, podobna.
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.
Če bolnik izpusti odmerek zdravila Juluca, ga mora vzeti z obrokom čim prej, pod pogojem, da je do naslednjega odmerka še več kot 12 ur.
The most severe adverse reaction, possibly related to the treatment with dolutegravir (from pooled from Phase IIb and Phase III clinical studies), seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Najhujši neželeni učinek, morda povezan z zdravljenjem z dolutegravirjem (iz združenih kliničnih študij faz IIb in III), ugotovljen pri enem bolniku, je bila preobčutljivostna reakcija z izpuščajem in hudimi učinki na jetrih (glejte poglavje 4.4).
→ Use of Juluca is not recommended.
→ Uporaba zdravila Juluca ni priporočljiva.
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.
Poleg tega je bila ugotovljena protivirusna aktivnost rilpivirina proti obsežni skupini primarnih izolatov HIV-1 skupine M (podtipi A, B, C, D, F, G, H) z IC50 od 0,07 do 1,01 nM ter primarnih izolatov skupine O z EC50 od 2,88 do 8,45 nM.
Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT)1A1.
Dolutegravir se izloča predvsem s presnovo z uridinfosfat-glukuronoziltransferazo (UGT)1A1.
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.
Po enkratnem peroralnem odmerku 14C-rilpivirina se je približno 85 % radioaktivnosti pojavilo v blatu in približno 6,1 % v urinu.
25-desacetyl-rifampicin
25-dezacetil-rifampicin
Dolutegravir has a terminal half-life of ~14 hours.
Terminalni razpolovni čas dolutegravirja je ~14 ur.
A reduction in the antiviral activity of rilpivirine was observed in the presence of 1 mg/mL alpha-1-acid glycoprotein, 45 mg/mL human serum albumin, and 50% human serum as demonstrated by median IC50 rates of 1.8, 39.2 and 18.5, respectively.
V prisotnosti 1 mg/ml alfa-1-kislega glikoproteina, 45 mg/ml človeškega serumskega albumina oziroma 50-odstotnega človeškega seruma so opažali zmanjšanje protivirusne aktivnosti rilpivirina, ki se je kazalo z medianimi razmerji IC50 1,8, 39,2 oziroma 18,5.
• joint pain, stiffness and bone problems.
• bolečine v sklepih, okorelost in težave s kostmi.
White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.
Bele plastenke iz HDPE (polietilena velike gostote), zaprte z zaporko, varno za otroke, in polietilensko prevlečenimi indukcijsko toplotno zaprtimi oblogami.
Drug Interactions Medicinal products by therapeutic areas
Preglednica 1: Medsebojno delovanje z zdravili Zdravila po terapevtskih področjih
Juluca film-coated tablets are pink, oval, biconvex tablets debossed with ‘SV J3T' on one side.
Filmsko obložene tablete zdravila Juluca so rožnate, ovalne in bikonveksne tablete, ki imajo na eni strani vtisnjeno oznako "SV J3T".
Dolutegravir is highly bound (>99%) to human plasma proteins based on in vitro data.
Na podlagi podatkov in vitro je dolutegravir v veliki meri (> 99 %) vezan na beljakovine v človeški plazmi.
The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in adult antiretroviral treatment-naïve HIV-1 infected patients.
Farmakokinetične lastnosti rilpivirina so ocenili pri zdravih odraslih preiskovancih in pri odraslih bolnikih, okuženih s HIV-1, ki še niso prejemali protiretrovirusnega zdravljenja.
The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Vpliv priporočenega odmerka 25 mg rilpivirina enkrat na dan na interval QTcF so ocenili v randomizirani, s placebom in zdravilno učinkovino (moksifloksacin 400 mg enkrat na dan) kontrolirani navzkrižni študiji pri 60 zdravih odraslih, pri katerih so v stanju dinamičnega ravnovesja opravili 13 meritev v 24 urah.
Investigations common creatine phosphokinase (CPK) elevations * Frequencies are assigned based on the maximum frequencies observed in the pooled SWORD studies or studies with the individual components ** This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs.
* Pogostnosti so opredeljene glede na največje pogostnosti, opažene v združenih študijah SWORD ali študijah s posameznima učinkovinama ** Ta neželeni učinek je bil ugotovljen med spremljanjem dolutegravirja v kombinaciji z drugimi protiretrovirusnimi zdravili po prihodu na trg.
From rilpivirine Phase III trials, in the week 48 pooled resistance analysis conducted with previously untreated patients, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
V analizi odpornosti iz združenih podatkov preskušanj rilpivirina faze III, opravljenih pri predhodno še nezdravljenih bolnikih, je 62 (od skupaj 72) bolnikov z virološkim neuspehom v skupini z rilpivirinom imelo podatke o odpornosti ob izhodišču in ob času neuspeha.
Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Dolutegravir ni bil mutagen ali klastogen v testih in vitro na bakterijah in gojenih sesalskih celicah ter in vivo v mikrojedrnem preizkusu pri glodalcih.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolnikom je treba pojasniti, da morajo v primeru bolečin v sklepih, okorelosti sklepov ali težav pri gibanju poiskati zdravniško pomoč.
Metformin is eliminated renally and therefore it is of importance to monitor renal function when co-treated with Juluca.
Metformin se izloča skozi ledvice, zato je med sočasnim zdravljenjem z zdravilom Juluca pomembno kontrolirati delovanje ledvic.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (SAMO POSAMIČNA PAKIRANJA)
Metabolic inducers may significantly decrease dolutegravir/rilpivirine plasma concentrations, resulting in loss of therapeutic effect.
Induktorji presnove lahko pomembno zmanjšajo koncentracijo dolutegravirja/rilpivirina v plazmi in povzročijo izgubo terapevtskega učinka.
Juluca should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Zdravilo Juluca je treba med sočasno uporabo z zdravili, ki imajo znano tveganje za nastanek Torsade de Pointes, uporabljati previdno.
In a DEXA substudy mean bone mineral density (BMD) increased from Baseline to Week 48 in subjects who switched to dolutegravir plus rilpivirine (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing antiretroviral regimen (0.05% total hip and 0.15% lumbar spine.
V podštudiji DEXA se je povprečna mineralna gostota kosti (MGK) od izhodišča do 48. tedna pri preiskovancih, ki so prešli na kombinacijo dolutegravirja in rilpivirina, povečala (1,34 % v celotnem kolku in 1,46 % v ledveni hrbtenici) v primerjavi s tistimi, ki so nadaljevali zdravljenje s protiretrovirusno shemo s TDF (0,05 % v celotnem kolku, 0,15 % v ledveni hrbtenici).
MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (SAMO SKUPNA PAKIRANJA - Z »BLUE BOX«)
In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Študija pri zdravih preiskovancih je pokazala, da supraterapevtski odmerki rilpivirina (75 mg enkrat na dan in 300 mg enkrat na dan) podaljšajo interval QTc na EKG (glejte poglavje 5.1).
Very common side effects These may affect more than 1 in 10 people:
Zelo pogosti neželeni učinki Pojavijo se lahko pri več kot 1 od 10 bolnikov:
Taking Juluca in fasted condition or with only a protein-rich nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of Juluca.
Jemanje zdravila Juluca na tešče ali samo z beljakovinsko bogatim prehranskim napitkom lahko povzroči zmanjšanje koncentracije rilpivirina v plazmi, to pa lahko zmanjša terapevtski učinek zdravila Juluca.
The absorption of dolutegravir is reduced by certain anti-acid medicinal products (see Table 1).
Določena antacidna zdravila zmanjšajo absorpcijo dolutegravirja (glejte Preglednico 1).
No treatment emergent resistanceassociated substitutions were observed for the other three subjects who experienced confirmed virologic failure.
Pri drugih treh preiskovancih s potrjenim virološkim neuspehom niso opazili med zdravljenjem nastalih, z odpornostjo povezanih substitucij.
As dolutegravir and rilpivirine are highly bound to plasma proteins, dialysis is unlikely to result in significant removal of the active substances.
Ker se dolutegravir in rilpivirin v veliki meri vežeta na beljakovine v plazmi, ni verjetno, da bi ju bilo mogoče v pomembni količini odstraniti z dializo.
Interaction Geometric mean change
Medsebojno delovanje Geometrijska sredina spremembe (%)
• symptoms of infections and inflammation
• simptomi okužb in vnetij,
No clinical data are available in patients with hepatitis B co-infection.
Kliničnih podatkov o bolnikih, sočasno okuženih s hepatitisom B, ni.
Multipacks containing 90 (3 packs of 30) film-coated tablets.
Skupna pakiranja z 90 (3 pakiranja po 30) filmsko obloženimi tabletami.
Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
Zdravniki morajo za vodenje okužbe s HIV pri bolnikih, sočasno okuženih z virusom hepatitisa B, upoštevati trenutno veljavne smernice za zdravljenje.
Musculoskeletal and connective tissue disorders uncommon arthralgia myalgia
Bolezni mišično skeletnega sistema in vezivnega tkiva občasni artralgija mialgija
Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Na voljo so tudi skupna pakiranja z 90 filmsko obloženimi tabletami (3 pakiranja po 30 filmsko obloženih tablet).
Juluca contains dolutegravir and rilpivirine, therefore any interactions identified with these active substances are relevant to Juluca.
Zdravilo Juluca vsebuje dolutegravir in rilpivirin, zato so zanj pomembna vsa medsebojna delovanja, ugotovljena za ti dve učinkovini.
This may result in loss of therapeutic effect of Juluca (induction of CYP3A enzymes).
To lahko povzroči izgubo terapevtskega učinka zdravila Juluca (indukcija encimov CYP3A).
Lower exposures of dolutegravir and rilpivirine were observed during pregnancy (see sections 4.2, 4.4, 5.1,
Med nosečnostjo so opažali manjšo izpostavljenost dolutegravirju in rilpivirinu (glejte poglavja 4.2,