FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilpivirine ↔ (Not studied).
Maltese: Rilpivirine ↔ (Ma ġiex studjat).
English: Rilpivirine ↔ (Not studied)
Maltese: Rilpivirine ↔ (Ma ġiex studjat)
English: Dolutegravir ↓ AUC ↓ 74% Cmax ↓ 72% C24 ↓ 74% (Complex binding to polyvalent ions).
Maltese: Dolutegravir ↓ AUC ↓ 74% Cmax ↓ 72% C24 ↓ 74% (Irbit kumpless ma' joni polivalenti).
English: *** The results of the pooled analysis are in line with those of the individual studies, for which differences in proportions meeting the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 (based on the Snapshot algorithm) for DTG+RPV versus CAR were -0.6 (95% CI: -4.3; 3.0) for SWORD-1 and 0.2 (95% CI: -3.9; 4.2) for SWORD-2 with a preset noninferiority margin of -10%.
Maltese: CAR kienu -0.6 (95% CI: -4.3; 3.0) għal SWORD-1 u 0.2 (95% CI: -3.9; 4.2) għal SWORD-2 b'marġini ta' non-inferjorità stabbilit minn qabel ta' -10%.
English: Antacids and supplements Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/
Maltese: aluminium magnesium hydroxide, u/jew calcium cardonate)/
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Maltese: Dolutegravir jiġi primarjament metabolizzat permezz ta' glukoronidazzjoni minn UGT1A1 b'komponent żgħir ta' CYP3A.
English: Juluca is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and rilpivirine.
Maltese: Juluca huwa mediċina li fiha żewġ ingredjenti attivi li jintużaw biex jikkuraw infezzjoni ta' virus talimmunodefiċjenza umana (HIV): dolutegravir u rilpivirine.
English: The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Maltese: L-effett tal-mutazzjonijiet ibbażati fuq Q148 (H/R/K) kien ukoll konsistenti mal-esperimenti fil passaġġ in vitro bil-mutanti diretti lejn is-sit.
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.
Maltese: R263K ġie rrappurtat minn żewġ pazjenti individwali b'sottotip B u sottotip Ċ fil-programm kliniku ta' Fażi
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT)1 and OAT3.
Maltese: In vitro, dolutegravir inibixxa t-trasportaturi ta' teħid mill-kliewi, it-trasportaturi anijoniċi organiċi (OAT)1 u
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
Maltese: IIb u l-Fażi III, ma ntwera l-ebda żvilupp għal reżistenza għal klassi ta' integrase, jew għall-klassi NRTI (n=876, segwitu ta' 4896 ġimgħa).
English: Antidiabetics
Maltese: Antikoagulanti
English: 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.
Maltese: Żewġ individwi fost l-istudji miġbura SWORD-1 (201636) u SWORD-2 (201637) minn kull fergħa ta' kura esperjenzaw insuffiċjenza viroloġika kkonfermata li wasslet għal irtirar fi kwalunkwe ħin matul Ġimgħa 48.
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).
Maltese: Dolutegravir ma affettwax il-fertilità tal-irġiel jew tan-nisa fil-firien b'dożi sa 1000 mg/kg/jum, l-ogħla doża ttestjata (33 darba tal-esponiment kliniku għall-bniedem ta' 50 mg abbażi tal-AUC).
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: L-effett ta' Juluca fuq in-nisa tqal mhux magħruf.
English: This patient's viral load was 1,059,771 copies/mL at the suspected virologic withdrawal visit and was <50 copies/mL at the withdrawal visit.
Maltese: It-tagħbija virali tal-pazjent kienet 1,059,771 kopja/mL fi żjara ta' rtirar viroloġiku suspettat u kienet <50 kopja/mL fil-vista ta' rtirar.
English: In patients with prior failed therapies, but naïve to the integrase class (SAILING study), integrase inhibitor substitutions were observed in 4/354 patients (follow-up 48 weeks) treated with dolutegravir, which was given in combination with an investigator selected background regimen (BR).
Maltese: F'pazjenti b'terapiji li ma rnexxewx preċedentement, iżda naïve għall-klassi ta' integrase (studju SAILING), ġew osservati sostituzzjonijiet tal-inibitur integrase f'4/354 pazjent (segwitu ta' 48 ġimgħa) ikkurati b'dolutegravir, li ngħata flimkien ma' reġimen ta' sfond (BR, background regimen) magħżul millinvestigatur.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 30 and 1.2 times the 50 mg human clinical exposure based on AUC, respectively.
Maltese: L-effett primarju ta' dolutegravir kien intolleranza gastrointestinali jew irritazzjoni fil-firien u fix-xadini b'dożi li jipproduċu esponimenti sistemiċi ta' madwar 30 darba u 1.2 drabi l-esponiment kliniku tal-bniedem ta' 50 mg abbażi tal-AUC, rispettivament.
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Maltese: Fil-provi, il-preżenza tal-mutazzjonijiet V90I u V189I fil-linja bażi, ma affettwatx ir-rispons.
English: In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Maltese: F'esperimenti ta' selezzjoni oħrajn permezz ta' iżolati kliniċi tas-sottotip B, ġiet osservata mutazzjoni R263K fil-ħames iżolati kollha (minn 20 ġimgħa 'l quddiem).
English: Juluca may replace your current antiretroviral medicines.
Maltese: Juluca jista' jissostitwixxi l-mediċini antiretrovirali attwali tiegħek.
English: Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Maltese: Abbażi ta' din id-data, dolutegravir mhuwiex mistenni li jaffettwa l farmakokinetika ta' prodotti mediċinali li huma substrati ta' dawn l-enzimi jew trasportaturi (ara sezzjoni 4.5).
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.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata bħala multifattorjali (inkluż użu ta' kortikosterojdi, bisfosfonati, ilkonsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem ogħla), ġew irrappurtati każijiet ta' osteonekrożi partikolarment f'pazjenti b'mard avvanzat tal-HIV u/jew esponiment fit-tul għal CART.
English: Co-infection with Hepatitis B or C
Maltese: Koinfezzjoni b'Epatite B jew Ċ
English: Selected established and theoretical interactions between dolutegravir, rilpivirine and co-administered medicinal products are listed in Table 1.
Maltese: L-interazzjonijiet magħżula u teoretiċi bejn dolutegravir, rilpivirine u prodotti mediċinali mogħtija flimkien huma elenkati f'Tabella 1.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Maltese: Kull pillola miskija b'rita fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir u rilpivirine hydrochloride ekwivalenti għal 25 mg rilpivirine.
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (38 times the 50 mg human clinical exposure based on AUC).
Maltese: L-għoti orali ta' dolutegravir lill-firien tqal b'dożi sa 1000 mg/kg kuljum minn jiem 6 sa 17 tal-ġestjoni ma wassalx għal tossiċità materna, tossiċità tal-iżvilupp jew teratoġeniċità (38 darba l-50 mg esponiment kliniku tal-bniedem abbażi tal-AUC).
English: 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).
Maltese: Juluca huwa indikat għall-kura ta' infezzjoni ta' virus ta' tip 1 tal-immunodefiċjenza umana (HIV‑1)f'adulti li huma viroloġikament soppressi (HIV-1 RNA <50 kopja/mL) fuq reġimenen antiretrovirali stabbli għal talinqas sitt xhur bl-ebda storja ta' insuffiċjenza viroloġika u bl-ebda reżistenza magħrufa jew issuspettata għal xi inibitur ta' traskriptażi inversi mhux nukleosidu jew inibitur ta' integrase (ara sezzjoni 5.1).
English: Virologic Outcomes of Randomized Treatment at Week 48 (Snapshot algorithm)
Maltese: Eżiti Viroloġiċi tal-Kura Randomiseda f'Ġimgħa 48 (Algoritmu snapshot)
English: Multivitamin/ Dolutegravir1
Maltese: Multivitamina/ Dolutegravir1
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on a 50 kg human), and 11 times the human mg/m2 equivalent dose for a clinical dose of 50 mg.
Maltese: Intolleranza GI fix-xadini seħħet fi 30 darba d-doża ekwivalenti mg/kg tal-bniedem (abbażi ta' 50 kg tal-bniedem ), u 11-il darba d-doża ekwivalenti mg/m2 tal-bniedem għal doża klinika ta' kuljum totali ta'
English: The pooled primary analysis demonstrated that dolutegravir plus rilpivirine is non-inferior to CAR, with 95% of subjects in both arms achieving the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm (Table 3).
Maltese: b'95 % tal-individwi fiż-żewġ fergħat li rċivew l-end-point primarju ta' <50 kopja/mL ta' RNA tal-HIV-1 fil-plażma f'Ġimgħa 48 abbażi tal-algorittmu Snapshot (Tabella 3).
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: (CART), tista' sseħħ reazzjoni infjammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali u jikkawżaw kondizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Maltese: Dolutegravir jiġi assorbit malajr wara għoti orali, b'Tmax medjana 2 sa 3 sigħat wara d-doża għallformulazzjoni tal-pillola.
English: The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Maltese: Il-farmakokinetika ġiet evalwata fi 11-il wild ta' età ta' 6 sa 12-il sena u wriet li 25 mg darba kuljum fil-pazjenti li jiżnu tal-inqas 20 kg u 35 mg darba kuljum f'pazjenti li jiżnu tal-inqas 30 kg irriżulta f'esponiment għal dolutegravir komparabbli għall-adulti.
English: Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Juluca ma' rifampicin huwa kontraindikat (ara sezzjoni 4.3).
English: Talc
Maltese: Sess
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).
Maltese: end-point tal-effikaċja primarju għall-istudji SWORD kien il-proporzjon ta' individwi b'RNA ta' HIV-1 fil plażma ta' <50 kopja/mL f'Ġimgħa 48 (Algorittmu snapshot għall-popolazzjoni ITT-E).
English: Dolutegravir and rilpivirine are both primarily metabolized and eliminated by the liver.
Maltese: Dolutegravir u rilpivirine t-tnejn jiġu metabolizzati u eliminati primarjament mill-fwied.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Maltese: metformin meta jinbeda u jitwaqqaf l-għoti flimkien ta' Juluca ma' metformin, biex jinżamm kontroll gliċemiku.
English: Immune system disorders uncommon hypersensitivity (see section 4.4) not known immune reconstitution syndrome
Maltese: Disturbi fis-sistema immuni mhux komuni sensittività eċċessiva (ara sezzjoni 4.4)
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1).
Maltese: dożi supraterapewtiċi ta' rilpivirine (75 mg darba kuljum u 300 mg darba kuljum) intwerew li jtawlu l intervall tal-QTc tal-ECG (ara sezzjoni 5.1).
English: Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Juluca ma' inibituri tal-pompa tal-proton huwa kontraindikat (ara sezzjoni 4.3).
English: • clarithromycin and erythromycin, to treat bacterial infections
Maltese: • clarithromycin u erythromycin, biex jikkuraw infezzjonijiet batteriċi
English: H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) H2 receptor antagonist medicines can stop Juluca being absorbed into your body and make it less effective.
Maltese: Antagonisti tar-riċettur H2 (pereżempju cimetidine, famotidine, nizatidine, ranitidine) Mediċini ta' antagonisti tar-riċettur H2 jistgħu jwaqqfu milli Juluca jiġi assorbit f'ġismek u jagħmluh inqas effettiv.
English: Subjects with hepatitis B co-infection or hepatitis C infection in need of anti-HCV therapy were excluded from studies with the dual combination of dolutegravir and rilpivirine.
Maltese: Individwi b'koinfezzjoni talepatite B jew b'infezzjoni tal-epatite Ċ li jeħtieġu terapija kontra HCV ġew esklużi mill-istudji bilkombinazzjoni doppja ta' dolutegravir u rilpivirine.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali b'terapija antiretrovirali effettiva ġiet ippruvata li tnaqqas b'mod sostanzjali rriskju ta' trażmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy subjects and in adult antiretroviral treatment-naïve HIV-1 infected patients.
Maltese: Il-karatteristiċi farmakokinetiċi ta' rilpivirine ġew evalwati f'individwi b'saħħithom adulti u f'pazjenti adulti infettati bl-HIV-1 li qatt ma ħadu kura antiretrovirali.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Maltese: Iddistribuzzjoni ta' rilpivirine f'kompartimenti apparti l-plażma (eż., fluwidu ċerebrospinali, sekrezzjonijiet fl apparat ġenitali) ma ġietx evalwata fl-bnedmin.
English: In 100% human serum, the dolutegravir mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Maltese: Effett tas-seru tal-bniedem u tal-proteini tas-seru F'seru 100 % tal-bniedem, il-bidla medja fid-drabi tal-proteini ta' dolutegravir kienet ta' 75 darba, u dan irriżulta f'IC90 aġġustat għall-proteina ta' 0.064 µg/mL.
English: There are limited data available on the use of Juluca in patients aged 65 years and over.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' Juluca f'pazjenti li għandhom 65 sena u aktar.
English: Co-administration of Juluca with rifapentine is contraindicated (see section 4.3).
Maltese: rifapentine huwa kontraindikat (ara sezzjoni 4.3).
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Maltese: Prodotti mediċinali li jinduċu jew jinibixxu CYP3A jistgħu għaldaqstant jaffettwaw it-tneħħija ta' rilpivirine (ara sezzjoni 5.2).
English: 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.
Maltese: Ġiet osservata taħlita K101K/E ta' sostituzzjoni assoċjata ma' reżistenza għal NNRTI bl-ebda suxxettibbiltà mnaqqsa għal rilpivirine (FC=1.2) f'individwu wieħed bi kwistjonijiet ta' aderenza identifikati li rċieva dolutegravir flimkien ma' rilpivirine.
English: Analgesics Methadone/ Dolutegravir1
Maltese: Methadone/ Dolutegravir1
English: • muscle pain.
Maltese: • uġigħ fil-muskoli
English: The R263K mutation was also selected in vitro (see above).
Maltese: Ilmutazzjoni R263K kienet ukoll magħżula in vitro (ara hawn fuq).
English: Metformin is eliminated renally and therefore it is of importance to monitor renal function when co-treated with Juluca.
Maltese: Metformin jiġi eliminat mill-kliewi u għalhekk huwa ta' importanza li tiġi mmonitorjata l-funzjoni tal-kliewi meta jingħata flimkien ma' Juluca.
English: 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.
Maltese: Wara għoti orali ta' doża waħda ta' 14C‑rilpivirine, bħala m edja 85 % u 6.1 % tar-radjuattività setgħet tinkiseb lura fl-ippurgar u fl awrina, rispettivament.
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Maltese: 1 L/hr f'pazjenti infettati bl-HIV abbażi ta' analiżi tal-farmokinetika tal-popolazzjoni.
English: These medicinal products are recommended to be administered 6 hours before or 4 hours after Juluca (see section 4.5).
Maltese: Dawn il-prodotti mediċinali huma rakkomandati li jingħataw 6 sigħat qabel jew 4 sigħat wara Juluca (ara sezzjoni 4.5).
English: Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Maltese: Dolutegravir jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali fejn l-eskrezzjoni hija dipendenti fuq OAT3.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
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.
Maltese: Ir-reazzjonijiet avversi li ġew ikkunsidrati tal-inqas possibbilment relatati mal-kura bil-komponenti ta' Juluca minn studji kliniċi u esperjenza ta' wara t-tqegħid fis-suq huma elenkati f'Tabella 2 skont is-sistema tal ġisem, il-klassifika tal-organi u l-frekwenza.
English: Population pharmacokinetic analyses from studies with the individual components revealed that gender had no clinically relevant effect on the pharmacokinetics of dolutegravir or rilpivirine.
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni minn studji bil-komponenti individwali wrew li s-sess ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' dolutegravir jew rilpivirine.
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Maltese: Fi 13-il individwu bla esperjenza ta' kura fuq reġimen stabbli ta' dolutegravir flimkien ma' abacavir/lamivudine, il-konċentrazzjoni ta' dolutegravir fis-CSF kellha medja ta' 18 ng/mL (komparabbli mal-konċentrazzjoni mhux marbuta fil plażma, u 'l fuq mill-IC50).
English: Rilpivirine ↑ Not studied.
Maltese: Rilpivirine ↓ Ma ġiex studjat.
English: When Juluca is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day should be taken at the same time with Juluca, for the duration of the rifabutin co-administration (a separate formulation of rilpivirine is available for this dose adjustment, see section 4.2).
Maltese: rilpivirine kuljum fl-istess ħin ma' Juluca, sakemm jibqa' jingħata flimkien ta' rifabutin (hemm disponibbli formulazzjoni separata ta' rilpivirine għal dan l-aġġustament fid-doża, ara sezzjoni 4.2).
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Maltese: F'din l-analiżi, il-mutazzjonijiet assoċjati mar-reżistenza (RAMs, resistance-associated mutations) b'reżistenza għal NNRTI li żviluppaw f'tal-inqas 2 insuffiċjenzi viroloġiċi ta' rilpivirine kienu: V90I, K101E, E138K, E138Q, V179I, Y181C,
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults.
Maltese: Ma kien hemm l-ebda sejba tas-sigurtà ġdida meta mqabbla mal-profil tas-sigurtà magħruf ta' rilpivirine f'adulti infettati bl-HIV-1.
English: Dose dependent decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes).
Maltese: Huwa mistenni tnaqqis fil konċentrazzjonijiet filplażma ta' rilpivirine dipendenti fuq id-doża (induzzjoni ta' enzimi ta' CYP3A).
English: What Juluca contains - The active substances are dolutegravir and rilpivirine.
Maltese: X'fih Juluca - Is-sustanzi attivi huma dolutegravir u rilpivirine.
English: Population pharmacokinetic analysis using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir or rilpivirine exposures.
Maltese: L-analiżi tal-farmokokinetika tal-popolazzjoni permezz ta' data fl-adulti infettati bl-HIV-1 uriet li ma kien hemm l-ebda effett klinikament rilevanti tal-età fuq l-esponimenti ta' dolutegravir jew rilpivirine.
English: A dose adjustment of metformin should be considered when starting and stopping co-administration of Juluca with metformin, to maintain glycaemic control (see section 4.5).
Maltese: Għandu jiġi kkunsidrat aġġustament fid-doża ta' metformin meta jinbeda u jitwaqqaf l-għoti ta' Juluca flimkien ma' metformin, biex jinżamm kontroll gliċemiku (ara sezzjoni 4.5).
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Maltese: Rilpivirine f'kombinazzjoni ma' reġimenen ta' sfond ġie evalwat fi prova klinika ta' 19-il mara tqal waqt it tieni u t-tielet trimestri, u wara t-tqala.
English: Hepatic impairment
Maltese: Ipproteġi nies oħra
English: You need to know about important signs and symptoms to look out for while you're taking Juluca.
Maltese: Jeħtieġ li tkun taf dwar sinjali u sintomi importanti li għandek toqgħod attent għalihom meta tkun qed tieħu Juluca.
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Maltese: In-nofs ħajja terminali tal-eliminazzjoni ta' rilpivirine hija ta' madwar 45 siegħa.
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).
Maltese: F'data limitata minn numri żgħar ta' nisa li rċievew dolutegravir 50 mg darba kuljum f'kombinazzjoni ma' reġimenen ta' sfond, l-esponiment totali (AUC) għal dolutegravir kien 37% iktar baxx matul it-tieni trimestru tat-tqala, u 29% aktar baxx matul it-3 trimestru tat-tqala, meta mqabbel ma' wara t-twelid (6-12-il ġimgħa).
English: Juluca film-coated tablets are pink, oval, biconvex tablets debossed with ‘SV J3T' on one side.
Maltese: Juluca pillola miksija b'rita huma pilloli roża, ovali, bikonvessi mnaqqxa b'“SV J3T” fuq naħa waħda.
English: Digoxin/ Dolutegravir Digoxin/ Rilpivirine1
Maltese: Digoxin/ Rilpivirine1