FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant).
Maltese: - Mediċini li jistgħu jżidu l-livelli tal-potassium fid-demm bħal dijuretiċi li ma jipproduċux potassium, supplimenti tal-potassium, sostituti tal-melħ li jkun fihom il-potassium, inibituri ta' ACE, cyclosporin (mediċina immunosoppressanti) u prodotti mediċinali oħrajn bħal heparin sodium (antikoagulant).
English: Other medicines and PritorPlus:
Maltese: Mediċini oħra u PritorPlus
English: CLINICAL PARTICULARS
Maltese: Disfunzjoni erettili
English: Hypercalcaemia
Maltese: Hydrochlorothiazide
English: PritorPlus is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg Renal impairment
Maltese: PritorPlus hu disponibbli wkoll f'dożi b'qawwa ta' 40 mg/12.5 mg u 80 mg/ 12.5 mg
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in PritorPlus, minimal or no effects were reported.
Maltese: Żieda fil-livelli tal-kolesterol u tat-trigliċeridi kienet assoċjata ma' terapija dijuretika b'thiazide; madankollu, bid-doża ta' 12.5 mg li hemm fi PritorPlus, effetti minimi kienu rrappurtati, jew l-ebda effett.
English: Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, , serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Maltese: Infjammazzjoni tal-glandola tal-bżieq, kanċer tal-ġilda u tax-xoffa (kanċer tal-ġilda mhux melanoma), tnaqqis fin-numru (jew anke nuqqas) ta' ċelluli fid-demm, li jinkludu għadd baxx taċ-ċelluli tad-demm ħomor u taċ-ċelluli tad-demm bojod, reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), tnaqqis jew telf tal-aptit, nuqqas ta' kwiet f'ġismek, sturdament, vista mċajpra jew tara kollox isfar, tnaqqis fil-vista u wġigħ fl-għajnejn (sinjali possibbli ta' mijopja akuta jew glawkoma ta' angolu magħluq), infjammazzjoni tal-vini jew arterji (vaskulite nekrotizzanti), frixa infjammata, stonku mqalleb, sfurija tal-ġilda jew ta' l-għajnejn (suffejra), sindrome qisu lupus (kundizzjoni li tixbah ħafna lil marda msejħa lupus erythematosus sistemiku fejn is-sistema immuni tal-ġisem tattakka lill-ġisem); disturbi tal-ġilda bħal vini jew arterji infjammati, żieda fis-sensittività għad-dawl taxxemx, raxx, ħmura tal-ġilda, infafet fix-xufftejn, għajnejn jew ħalq, tqaxxir tal-ġilda, deni (sinjali possibbli ta' eritema multiforme), dgħufija, infjammazzjoni tal-kliewi jew indeboliment fil-funzjoni tal-kliewi, glucose fl-awrina (glikosurija), deni, indeboliment fil-bilanċ tal-elettroliti, livelli għolja ta' kolesterol fid-demm, tnaqqis fil-volum tad-demm, żieda fil-livell tal-glucose fid-demm, diffikultajiet biex tikkontrolla l-livelli tal-glucose fid-demm/awrina f'pazjenti b'dijanjosi ta' dijabete mellitus, jew xaħam fid-demm.
English: Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).
Maltese: Itthiazides għandhom jintużaw b'attenzjoni f'pazjenti b'funzjoni epatika indebolita (ara sezzjoni 4.4).
English: Telmisartan: Following oral administration peak concentrations of telmisartan are reached in 0.5 - 1.5 h after dosing.
Maltese: Wara l-għoti mill-ħalq, konċentrazzjonijiet massimi ta' telmisartan jintlaħqu wara 0.5 - 1.5 siegħa wara d-dożaġġ.
English: Hydrochlorothiazide: Following oral administration of PritorPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Maltese: Wara l-għoti ta' PritorPlus mill-ħalq, il-konċentrazzjonijiet massimi ta' hydrochlorothiazide jintlaħqu wara madwar 1.0 - 3.0 sigħat wara d-dożaġġ.
English: Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Maltese: Monitoraġġ perjodiku tal-livell tal-potassium fis-serum u ECG huma rakkomandati meta PritorPlus jingħata ma' prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum (eż. digitalis glycosides, u anti-arritimiċi) u mal-prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti-arritimici), bl-ipokalemija, li hi fattur li jippredisponi t-torsades de pointes.
English: PritorPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Maltese: PritorPlus hu taħlita ta' żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f'pillola waħda.
English: Hydrochlorothiazide exhibits linear pharmacokinetics
Maltese: .2 Tagħrif farmakokinetiku
English: Antidiabetic medicinal products (oral agents and insulin)
Maltese: Prodotti mediċinali kontra d-dijabete (mediċini li jittieħdu mill-ħalq u insulina)
English: Sialadenitis
Maltese: Sturdament
English: Antidiabetic medicinal products (oral agents and insulin) Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Maltese: Aġġustament fid-doża ta' prodotti mediċinali kontra d-dijabete jista' jkun meħtieġ (ara sezzjoni 4.4).
English: The overall incidence and pattern of adverse reactions reported with PritorPlus 80 mg/25 mg was comparable with PritorPlus 80 mg/12.5 mg. A dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Maltese: L-inċidenza totali u l-andament ta' l-reazzjonijiet avversi rrappurtati bi PritorPlus 80 mg/25 mg kienu komparabbli ma' dawk bi PritorPlus 80 mg/12.5 mg.
English: Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Maltese: Telemisartan hu antagonist effettiv li jingħata mill-ħalq, tar-riċetturi ta' angiotensin II (tip AT1).
English: Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Maltese: Studji b'hydrochlorothiazide urew evidenza ekwivoka għal effett ġenotossiku jew karċinoġeniku f'xi mudelli sperimentali.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered
Maltese: Meta jkun klinikament xieraq, bidla diretta minn monoterapija għat-taħlita tista' tkun ikkunsidrata.
English: Thiazide diuretics may increase serum calcium levels due to the decreased excretion.
Maltese: Dijuretiċi thiazide jistgħu jżidu l-livelli tal-calcium fis-serum minħabba tnaqqis fit-tneħħija.
English: MA (EU) Number
Maltese: Numru tal-MA (UE)
English: 160 µg / 4.5 µg Inhalation powder Inhalation use inhaler
Maltese: Il-pakkett li jmiss malprodott
English: Pack size
Maltese: 'għadux awtorizzat
English: *based on historic controls.
Maltese: *abbażi ta' kontrolli storiċi.
English: AUC: ↔* Cmin: ↔* Cmax: ↔*
Maltese: ↔* Cmin: ↔* Cmax: ↔*
English: Phosphodiesterase type 5 (PDE-5) inhibitors Sildenafil /
Maltese: Inibituri ta' phosphodiesterase tip 5 (PDE-5) Sildenafil /
English: ATC code: J05AR21
Maltese: J05AR21
English: SWORD-1 and SWORD-2 Pooled Data*** DTG + RPV N=513 n (%)
Maltese: SWORD-2*** DTG + RPV N=513 n (%)
English: Magnesium stearate Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate Lactose monohydrate Croscarmellose sodium Povidone (K30)
Maltese: Magnesium stearate Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate Lactose monohydrate Croscarmellose sodiku Povidone (K30)
English: Frequency category*
Maltese: Kategorija ta' frekwenza*
English: INFORMATION IN BRAILLE juluca
Maltese: INFORMAZZJONI BIL-BRAILLE juluca
English: Potential increase via inhibition of OCT2 transporter.
Maltese: Żieda potenzjali permezz ta' inibizzjoni tat-trasportatur OCT2.
English: • hyperactivity (excessive restlessness and movement)
Maltese: • attività eċċessiva (irrekwjetezza u moviment eċċessivi)
English: (Not studied)
Maltese: (Ma ġiex studjat)
English: Liver problems including hepatitis B and/or C
Maltese: Problemi tal-fwied inkluż epatite B u/jew Ċ
English: Juluca contains dolutegravir.
Maltese: Juluca fih dolutegravir.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Maltese: Data ta 'l-ewwel awtorizzazzjoni: 16 ta' Mejju 2018
English: Ethinyl estradiol (EE)1 and Norethindrone1/ Rilpivirine
Maltese: Ethinyl estradiol (EE)1 u Norethindrone1/ Rilpivirine
English: Oral contraceptives Ethinyl estradiol (EE)1 and Norelgestromin (NGMN)1 / Dolutegravir
Maltese: Ethinyl estradiol (EE)1 u Norelgestromin (NGMN)1 / Dolutegravir
English: Rilpivirine inhibits P-gp in vitro (IC50 is 9.2 μM).
Maltese: Rilpivirine jinibixxi P‑gp in vitro (IC50 hi 9.2 μM).
English: • rifabutin, to treat tuberculosis (TB) and other bacterial infections.
Maltese: • rifabutin, biex jikkura t-tuberkulożi (TB) u infezzjonijiet batteriċi oħra.
English: AUC ↓ 9% Cmin NA
Maltese: AUC ↓ 9% Cmin MA
English: Dolutegravir has a terminal half-life of ~14 hours.
Maltese: Dolutegravir għandu half life terminali ta' ~14-il siegħa.
English: Adjusted difference (95% CI) -0.6 (-1.7, 0.6).
Maltese: Differenza aġġustata (CI ta' 95 %) -0.6
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Maltese: Rilpivirine jeħel madwar 99.7 % mal-proteini fil-plażma in vitro, primarjament ma'albumin.
English: Baseline CD4+ (cells/ mm3)
Maltese: CD4+ fil-Linja Bażi (ċelluli/ mm3)
English: Dolutegravir is present in cerebrospinal fluid (CSF).
Maltese: Dolutegravir huwa preżenti fil-fluwidu ċerebrospinali (CSF, cerebrospinal fluid).
English: Azole anti-fungals Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
Maltese: Antifungali ta' azole Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
English: Rilpivirine is primarily metabolised by CYP3A.
Maltese: Rilpivirine jiġi primarjament metabolizzat minn CYP3A.
English: Manufacturer Glaxo Wellcome, S.A. Avda.
Maltese: Il-Manifattur Glaxo Wellcome, S.A. Avda.
English: Immune Reactivation Syndrome
Maltese: Sindrome ta' Riattivazzjoni Immuni
English: In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Maltese: Fl-iżolati tas-sottotip C (n=2) u A/G (n=2) intgħażlet is-sostituzzjoni ta'integrase R263K f'iżolat wieħed, u G118R f'żewġ iżolati.
English: Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1.
Maltese: Rilpivirine huwa inibitur ta' non nucleoside reverse transcriptase ta' diarylpyrimidine tal-HIV-1 (NNRTI).
English: Rilpivirine demonstrated limited in vitro activity against HIV-2 with IC50 values ranging from 2,510 to 10,830 nM.
Maltese: Rilpivirine wera attività in vitro limitata kontra l-HIV-2 b'valuri IC50 li varjaw minn 2,510 sa 10,830 nM.
English: Combinations of multiple substitutions T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R or K, Q148R/N155H, T97A/G140S/Q148, and substitutions at
Maltese: Kombinazzjonijiet ta' sostituzzjonijiet multipli T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R jew K, Q148R/N155H, T97A/G140S/Q148, u sostituzzjonijiet b'E138/G140/Q148 urew tnaqqis ta' aktar minn 2 darbiet issuxxettibbiltà ta' dolutegravir (medda: 2.5 darbiet għal 21 darbiet mir-referenza).
English: In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1).
Maltese: In vitro, dolutegravir inibixxa t-trasportatur tal-ketajin renali organiku 2 (OCT2, organicketajin transporter 2) u t-trasportatur ta' diversi mediċini u estrużjoni tat-tossini 1 (MATE1).
English: Repeated dose toxicity
Maltese: Effett tossiku minn dożi ripetuti
English: • increase in cholesterol
Maltese: • żieda fil-kolesterol
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Maltese: Rilpivirine żamm sensittività ( (FC ≤ BCO) kontra 62 % ta' 4786 iżolat kliniku rikombinanti tal-HIV-1 reżistenti għal efavirenz u/jew nevirapine.
English: HMG CO-A reductase inhibitors Atorvastatin/
Maltese: Inibituri ta' HMG CO‑A reductase Atorvastatin/
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Maltese: Is-sostituzzjoni E138K dehret bl-aktar mod frekwenti waqt kura b'rilpivirine, l-aktar komuni f'kombinazzjoni mas-sostituzzjoni M184I.
English: Hepatobiliary disorders very common increased transaminases (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations)
Maltese: Disturbi fil-fwied u filmarrara komuni ħafna transaminases miżjuda elevazzjonijiet ta' alanine aminotransferase (ALT) u/jew aspartate aminotransferase (AST)
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT)1A1.
Maltese: Dolutegravir jiġi eliminat prinċipalment permezz tal-metaboliżmu minn uridine diphosphate glucuronosyl transferase 1A1 (UGT).
English: Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with ‘SV J3T' on one side.
Maltese: Pilloli roża, ovali, bikonvessi, madwar 14 x 7 mm, imnaqqxa b'“SV J3T” fuq naħa waħda.
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes).
Maltese: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induzzjoni ta' enzimi ta' UGT1A1 u CYP3A).
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09
Maltese: L-IC50 medju għal 3 iżolati ta' HIV-2 kienet 0.18 nM (medda 0.09
English: • increase in pancreatic amylase (a digestive enzyme).
Maltese: • żieda fl-amilażi pankreatika (enzima ta' diġestjoni).
English: 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.
Maltese: Ġie osservat tnaqqis fl-attività antivirali ta' rilpivirine fil-preżenza ta' 1 mg/mL alpha-1-acid glycoprotein, 45 mg/mL albumin fis-seru tal-bniedem, u 50 % fis-seru tal-bniedem muri minn rati IC50 medjani ta' 1.8, 39.2 u 18.5, rispettivament.
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).
Maltese: povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, lactose monohydrate, croscarmellose sodium, povidone (K30), polysorbate 20, silicified microcrystalline cellulose, polyvinyl alcohol- parzjalment idrolizzat, titanium dioxide (E171), macrogol, talc, iron oxide isfar (E172), iron oxide aħmar (E172).
English: Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Maltese: Sustanzi attivi antivirali Tenofovir disoproxil / Dolutegravir1
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).
Maltese: In vivo, dolutegravir jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali fejn l-eskrezzjoni hija dipendenti fuq OCT2 jew MATE-1 (eż. dofetilide, metformin) (ara Tabella 1 u sezzjonijiet 4.3 u 4.4).
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Maltese: Mill-analiżi ta' ġimgħa 48 sa ġimgħa 96, seħħew 24 (3.5%) u 14 (2.1%)-il insuffiċjenza viroloġika addizzjonali fil-fergħa ta' rilpivirine u efavirenz, rispettivament.
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.
Maltese: Il-mutazzjonijiet primarji għal raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) ma jaffettwawx is-suxxettibbiltà in vitro ta' dolutegravir bħala mutazzjonijiet uniċi.
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni “Effetti sekondarji oħra possibbli” f'sezzjoni 4 ta' dan il-fuljett.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median IC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Maltese: Rilpivirine wera attività kontra razez tal-laboratorju tat-tip selvaġġ HIV-1 f'linja ta' ċelluli T infettat b'mod akut b'valur IC50 medjan għall-HIV-1/IIIB ta' 0.73 nM (0.27 ng/mL).
English: While 24 infants were confirmed to be uninfected, 5 were indeterminate due to incomplete testing, see sections 4.2, 4.4 and 5.2.
Maltese: Filwaqt li 24 tarbija ġiet ikkonfermata li kienet mingħajr infezzjoni, 5 kienu indeterminati minħabba ttestjar mhux komplet, ara sezzjonijiet 4.2, 4.4 u 5
English: Dolutegravir or rilpivirine did not change ethinyl estradiol and norelgestromin (dolutegravir) or norethindrone (rilpivirine) plasma concentrations to a clinically relevant extent.
Maltese: Dolutegravir jew rilpivirine ma biddlux il konċentrazzjonijiet fil-plażma ta' ethinyl estradiol u norelgestromin (dolutegravir) jew norethindrone (rilpivirine) sa limitu klinikament rilevanti.
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Maltese: Abbażi tan-nuqqas ta' effett fuq il-farmakokinetika in vivo tas-substrat OAT tenofovir, l-inibizzjoni in vivo ta' OAT1 mhijiex probabbli.
English: Antimalarials Artemether/ Lumefantrine/ Dolutegravir
Maltese: Antimalarjali Artemether/ Lumefantrine/ Dolutegravir
English: 300 mg once daily (+ 25 mg once daily rilpivirine)
Maltese: 300 mg darba kuljum (+ 25 mg darba kuljum rilpivirine)
English: Using strain NL432, integrase mutations E92Q (fold change [FC] 3) and G193E (FC 3) were selected.
Maltese: Permezz tar-razza NL432 intgħażlu l-mutazzjonijiet E92Q (bidla fil valur [FC] ta' 3) u G193E (FC3).
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Maltese: Dehru IC50s simili għal iżolati kliniċi mingħajr ebda differenza ewlenija bejn is-sottotipi; f'pannell ta' 24 iżolat tal-HIV-1 ta' clades A, B, C, D, E, F u G u grupp O, il-valur IC50 medju kien 0.2 nM (medda 0.02-2.14).
English: (inhibition of intestinal P
Maltese: (inibizzjoni ta' P-gp intestinali).
English: Thirty-two percent of the total oral dose is excreted in the urine, mainly represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Maltese: Tnejn u tletin fil-mija tad-doża orali totali tiġi eliminata fl-awrina, prinċipalment irrappreżentata minn glucuronide ta' dolutegravir (18.9% tad-doża totali), metabolit N-dealkylation (3.6% tad-doża totali), u metabolit iffurmat bl-ossidazzjoni f'benzylic carbon (3.0% tad-doża totali).
English: Each film-coated tablet contains 52 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 52 mg lactose (bħala monohydrate).
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Maltese: Rilpivirine hu inibitur in vitro tat-trasportatur MATE-2K b'IC50 ta' < 2.7 nM.
English: Therefore, use of Juluca during pregnancy is not recommended (see sections 4.4, 4.6, 5.1 and 5.2).
Maltese: Għalhekk, l-użu ta' Juluca waqt it-tqala mhuwiex rakkomandat (ara sezzjonijiet 4.4, 4.6, 5.1 u 5.2).
English: Rifabutin/ Rilpivirine1 300 mg once daily2
Maltese: Rifabutin/ Rilpivirine1 300 mg darba kuljum2
English: Dolutegravir is highly bound (>99%) to human plasma proteins based on in vitro data.
Maltese: Dolutegravir jeħel ħafna (>99%) ma' proteini fil-plażma tal-bniedem abbażi ta' data in vitro.
English: Dolutegravir ↔ (Not studied)
Maltese: Dolutegravir ↔ (Ma ġiex studjat)
English: The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Maltese: Is-sostituzzjoni K103N waħidha ma rriżultatx f'suxxettibilità mnaqqsa għal rilpivirine minnha nnifisha, iżda l-kombinazzjoni ta' K103N u L100I irriżultat f'suxxettibilità 7 darbiet aktar imnaqqsa għal rilpivirine.
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
Maltese: In vitro, dolutegravir ma wera l-ebda inibizzjoni diretta jew wera inibizzjoni baxxa (IC50>50 μM) tal-enzimi taċ-ċitokromu P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A,
English: Dolutegravir activity was determined against a panel of 60 INI-resistant site-directed mutant HIV-1 viruses (28 with single substitutions and 32 with 2 or more substitutions).
Maltese: L-attività ta' dolutegravir ġiet determinata skont sensiela ta' 60 virus tal-HIV-1 mutanti diretti mis-sit reżistenti għall-INI (28 b'sostiuzzjoni waħda u 32 b'2 sostituzzjonijiet jew aktar).
English: CAR = current antiretroviral regimen; DTG+RPV = dolutegravir plus rilpivirine; INI = Integrase inhibitor; NNRTI = Non-nucleoside reverse transcriptase inhibitor; PI = Protease Inhibitor
Maltese: CAR = reġimen antiretrovirali attwali ; DTG+RPV = dolutegravir flimkien ma' rilpivirine; INI = Inibitur ta' integrase;
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Maltese: (żieda hija indikata bħala “↑”, tnaqqis huwa indikat bħala “↓”, l-ebda bidla hija indikata bħala “↔”, erja taħt il-kurva konċentrazzjoni kontra l-ħin bħala “AUC”, konċentrazzjoni osservata massima bħala “Cmax”, konċentrazzjoni fl-aħħar tal-intervall tad-dożaġġ bħala “Cτ”).
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes).
Maltese: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induzzjoni ta' enzimi ta' UGT1A1 u CYP3A).
English: The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Maltese: Il-volum apparenti tad-distribuzzjoni huwa 17 L sa 20 L f'pazjenti infettati bl-HIV, abbażi ta' analiżi talfarmokinetika tal-popolazzjoni.