FrancophonIA/ELRC3.0 huggingface dataset:
English: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai
Maltese: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni
English: Elvitegravir versus raltegravir
Maltese: Elvitegravir kontra raltegravir
English: Demographic characteristics Median age, years (min-max)
Maltese: Karatteristiċi demografiċi Medjan ta' età, snin (min-max)
English: HIV-1 RNA < 50 copies/mL, n/N (%)
Maltese: HIV-1 RNA < 50 kopja/mL, n/N (%)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13 ta' Novembru 2013
English: The active substance is elvitegravir.
Maltese: Is-sustanza attiva hi elvitegravir.
English: • anticonvulsants: carbamazepine, phenobarbital, phenytoin
Maltese: • antikonvulżanti: carbamazepine, phenobarbital, phenytoin
English: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172).
Maltese: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (parzjalment idrolizzat) (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172).
English: Vitekta contains lactose.
Maltese: Vitekta fih lactose.
English: Difference in percentages (95% CI)
Maltese: Differenza f'perċentwali (95% CI)
English: Croscarmellose sodium, hydroxypropyl cellulose, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.
Maltese: Croscarmellose sodium, hydroxypropyl cellulose, lactose (bħala monohydrate), magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate.
English: 0.8% (-17.7% to 19.3%)
Maltese: 0.8% (-17.7% sa 19.3%)
English: Polyvinyl alcohol (partially hydrolysed) (E1203)
Maltese: Polyvinyl alcohol (parzjalment idrolizzat) (E1203)
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Yellow iron oxide (E172)
English: Elvitegravir is a substrate for OATP1B1 and OATP1B3, and an inhibitor of OATP1B3 in vitro.
Maltese: Elvitegravir hu substrat għal OATP1B1 u OATP1B3, u inibitur ta' OATP1B3 in vitro.
English: 1.6% (-33.0% to 36.2%)
Maltese: 1.6% (-33.0% sa 36.2%)
English: Table 2: Interactions between elvitegravir and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn elvitegravir u prodotti mediċinali oħra
English: 126/202 (62.4%) 122/207 (58.9%) 3.4% (-6.0% to 12.9%) 2.9% (-13.7% to 19.6%)
Maltese: 126/202 (62.4%) 122/207 (58.9%) 3.4% (-6.0% sa 12.9%) 2.9% (-13.7% sa 19.6%)
English: Additional integrase substitutions observed in cell culture selection included H51Y, F121Y, S147G, S153Y, E157Q, and R263K.
Maltese: Sostituzzjonijiet addizzjonali ta' integrase osservati fil-koltura taċ-ċelluli kienu jinkludu H51Y, F121Y, S147G, S153Y, E157Q, u R263K.
English: -21.4% (-73.6% to 30.7%)
Maltese: -21.4% (-73.6% sa 30.7%)
English: 9.0% (-9.5% to 27.5%) -11.1% (-45.7% to 23.4%)
Maltese: 9.0% (-9.5% sa 27.5%) -11.1% (-45.7% sa 23.4%)
English: ↑ Ketoconazole§
Maltese: Tiqafx tieħu Vitekta
English: 7.1% (-47.1% to 61.4%)
Maltese: 7.1% (-47.1% sa 61.4%)
English: Vitekta is a treatment for human immunodeficiency virus (HIV) infection in adults aged 18 years
Maltese: Vitekta hu trattament għal infezzjoni bil-virus tal-immunodefiċjenza umana (HIV) f'adulti li
English: The in vitro antiviral activity of elvitegravir when combined with antiretroviral drugs from the nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI),
Maltese: L-attività antivirali in vitro ta' elvitegravir meta kkombinat ma' mediċini antiretrovirali min-nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), inibitur tal-protease (PI),
English: Elvitegravir is primarily metabolised by CYP3A.
Maltese: Elvitegravir jiġi metabolizzat primarjament minn CYP3A.
English: The most common substitutions that emerged in HIV-1 isolates from elvitegravir-treated subjects were T66I/A (n = 8), E92Q/G (n = 7), T97A (n = 4), S147G (n = 4), Q148R (n = 4), and N155H (n = 5) in integrase.
Maltese: L-iktar sostituzzjonijiet komuni li żviluppaw f'iżolati ta' HIV-1 minn individwi ttrattati b'elvitegravir kienu T66I/A (n = 8), E92Q/G (n = 7), T97A (n = 4), S147G (n = 4), Q148R (n = 4), u N155H (n = 5) f'integrase.
English: Co-administration of Vitekta with strong CYP3A inducers (including St. John's wort [Hypericum perforatum], rifampicin, carbamazepine, phenobarbital and phenytoin) is contraindicated (see sections 4.3 and 4.5).
Maltese: John's wort [Hypericum perforatum], rifampicin, carbamazepine, phenobarbital u phenytoin) hu kontraindikat (ara sezzjonijiet 4.3 u 4.5).
English: Elvitegravir is primarily metabolised by CYP3A (see section 5.2).
Maltese: Elvitegravir jiġi metabolizzat primarjament minn CYP3A (ara sezzjoni 5.2).
English: 105/202 (52.0%) 112/207 (54.1%) -2.1% (-11.8% to 7.5%) -1.5% (-18.2% to 15.3%)
Maltese: 105/202 (52.0%) 112/207 (54.1%) -2.1% (-11.8% sa 7.5%) -1.5% (-18.2% sa 15.
English: Table 1: Recommended dosing regimens Dose of Vitekta
Maltese: Tabella 1: Korsijiet rakkomandati ta' dożaġġ Doża ta' Vitekta
English: Interactions with CYP3A inducers
Maltese: Interazzjonijiet ma' indutturi ta' CYP3A
English: The HIV virus produces an enzyme called HIV integrase.
Maltese: Il-virus tal-HIV jipproduċi enzima msejħa integrase HIV.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/883/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/883/002
English: Of these 712 patients, 543 (269 elvitegravir and 274 raltegravir) and 439 (224 elvitegravir and 215 raltegravir) received at least 48 and 96 weeks of treatment, respectively.
Maltese: Minn dawn is-712-il pazjent, 543 (269 elvitegravir u 274 raltegravir) u 439 (224 elvitegravir u 215 raltegravir) irċivew mill-inqas 48 u 96 ġimgħa ta' kura, rispettivament.
English: Atorvastatin Fluvastatin Pitavastatin Pravastatin
Maltese: Prodott mediċinali skont iżżoni terapewtiċi
English: Table 4: Demographic and baseline disease characteristics of antiretroviral treatmentexperienced HIV-1 infected adult subjects in study GS-US-183-0145
Maltese: Tabella 4: Karatteristiċi demografiċi u fil-linja bażi tal-marda ta' individwi adulti infettati blHIV-1 li ngħataw trattament b'mediċini antiretrovirali fil-passat fi studju GS-US-183-0145
English: Excipient with known effect: Each tablet contains 6.2 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 6.2 mg ta' lactose (bħala monohydrate).
English: Phenotypic resistance to elvitegravir was most commonly associated with the primary integrase substitutions T66I, E92Q and Q148R.
Maltese: Reżistenza fenotipika għal elvitegravir kienet b'mod l-aktar komuni assoċjata mas-sostituzzjonijiet primarji ta' integrase T66I, E92Q u Q148R.
English: Vitekta 150 mg [Outer packaging only]
Maltese: Vitekta 150 mg [Pakkett ta' barra biss]
English: Cmax: ↓ 28%
Maltese: AUC: ↓ 28% Cmax: ↓ 28%
English: The in vitro antiviral activity of elvitegravir when combined with antiretroviral drugs from the nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand transfer inhibitor, fusion inhibitor, or CCR5 co-receptor antagonist classes showed no
Maltese: L-attività antivirali in vitro ta' elvitegravir meta kkombinat ma' mediċini antiretrovirali min-nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), inibitur tal-protease (PI), inibitur tat-trasferiment ta' integrase strand, inibitur tal-fużjoni, jew klassijiet ta' antagonisti ta' koriċettur CCR5, ma wriet l-ebda antagoniżmu.
English: The pharmacokinetic parameters of the protease inhibitors presented in Table 2 were assessed in the presence of ritonavir.
Maltese: Ilparametri farmakokinetiċi tal-inibituri tal-protease ippreżentati f'Tabella 2 ġew evalwati fil-preżenza ta' ritonavir.
English: Virologic success at week 48
Maltese: Suċċess viroloġiku f'ġimgħa 48
English: • bosentan, used to treat pulmonary arterial hypertension
Maltese: • bosentan, li tintuża għal trattament ta' pressjoni għolja arterjali pulmonari
English: With the exception of Y143C/R/H, HIV-1 with the primary raltegravir-associated substitutions T66K, Q148H/K/R, or N155H in integrase is associated with reduced susceptibility to elvitegravir.
Maltese: Bl-eċċezzjoni ta' Y143C/R/H, HIV-1 mas-sostituzzjonijiet primarji assoċjati ma' raltegravir T66K, Q148H/K/R, jew N155H f'integrase huma assoċjati ma' suxxettibilità mnaqqsa
English: In study GS-US-183-0145, diarrhoea was reported as an adverse reaction in 7.1% of subjects in the elvitegravir group and in 5.3% of subjects in the raltegravir group.
Maltese: Fi studju GS-US-183-0145, id-dijarea ġiet irrappurtata bħala reazzjoni avversa f'7.1% tal-individwi fil-grupp ta' elvitegravir u f'5.3% tal-individwi fil-grupp ta' raltegravir.
English: • carbamazepine, phenobarbital, phenytoin, used to treat epilepsy and prevent seizures
Maltese: • carbamazepine, phenobarbital, phenytoin, jintużaw għall-kura tal-epilessija u l-prevenzjoni ta' aċċessjonijiet
English: C]elvitegravir, 94.8% of the dose was recovered in faeces, consistent with the hepatobiliary elimination of elvitegravir; 6.7% of the administered dose was recovered in urine as metabolites.
Maltese: C]elvitegravir imsaħħaħ b'ritonavir, 94.8% tad-doża ġiet irkuprata flippurgar, u dan kien konsistenti mal-eliminazzjoni ta' elvitegravir mill-fwied u l-marrara; 6.7% taddoża mogħtija ġiet irkuprata fl-awrina bħala metaboliti.
English: Inhibition of integrase prevents the integration of HIV-1 DNA into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the viral infection.
Maltese: L-inibizzjoni ta' integrase timpedixxi l-integrazzjoni ta' HIV-1 DNA ġo host genomic DNA, u timblokka l-formazzjoni tal-HIV-1 provirus u l-propagazzjoni tal-infezzjoni virali.
English: Elvitegravir would also have potential to be a weak to modest inducer of CYP2B6 and CYP2C8 enzymes, as these enzymes are regulated in a similar manner to CYP2C9 and CYP3A.
Maltese: Elvitegravir ikollu wkoll il-potenzjal li jkun induttur minn dgħajjef sa modest ta' enzimi CYP2B6 u CYP2C8, għax dawn l-enzimi huma rregolati b'mod simili bħal CYP2C9 u CYP3A.
English: A study of the pharmacokinetics of boosted elvitegravir was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Studju dwar il-farmakokinetika ta' elvitegravir imsaħħaħ twettaq f'individwi li ma kinux infettati b'HIV-1 b'indeboliment epatiku moderat (Child-Pugh Klassi B).
English: Elvitegravir has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.4 and 5.2).
Maltese: Elvitegravir ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ) (ara sezzjonijiet 4.4 u 5.2).
English: • atazanavir and ritonavir
Maltese: • atazanavir u ritonavir
English: Green, pentagon-shaped, film-coated tablet of dimensions 8.9 mm x 8.7 mm, debossed with “GSI” on one side of the tablet and “85” on the other side of the tablet.
Maltese: Pillola miksija b'rita, ħadra, forma ta' pentagonu, b'daqs ta' 8.9 mm x 8.7 mm, b'“GSI” imnaqqxa fuq naħa waħda u n-numru “85” fuq in-naħa l-oħra.
English: Pack size: 1 bottle of 30 film-coated tablets.
Maltese: Daqs tal-pakkett: 1 flixkun ta' 30 pilloli miksija b'rita.
English: Mechanism of action and pharmacodynamic effects Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI).
Maltese: Elvitegravir hu inibitur tat-trasferiment ta' integrase strand ta' HIV-1 (HIV-1 integrase strand transfer inhibitor (INSTI)).
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of elvitegravir plus a ritonavir-boosted protease inhibitor (150 mg elvitegravir with darunavir or fosamprenavir; 85 mg elvitegravir with atazanavir or lopinavir) in HIV-1 infected subjects were 1.4 ± 0.39 μg/mL, 18 ± 6.8 μg•h/mL, and 0.38 ± 0.22 μg/mL for elvitegravir, respectively.
Maltese: Il-medja flistat fiss tas-Cmax, AUCtau, u Ctrough (medja ± SD) wara dożi multipli ta' elvitegravir flimkien ma' inibitur tal-protease imsaħħaħ b'ritonavir (150 mg elvitegravir ma' darunavir jew fosamprenavir; 85 mg elvitegravir ma' atazanavir jew lopinavir) f'individwi infettati bl-HIV-1, rispettivament, kienet 1.4 ± 0.39 μg/mL, 18 ± 6.8 μg•h/mL, u 0.38 ± 0.22 μg/mL għal elvitegravir, rispettivament.
English: Fosamprenavir (700 mg twice daily)
Maltese: Fosamprenavir (700 mg darbtejn kuljum)
English: Elvitegravir: AUC: ↑ 48% Cmax: ↔ Cmin: ↑ 67%
Maltese: AUC: ↑ 48% Cmax: ↔ Cmin: ↑ 67%
English: For example, atazanavir/ritonavir and lopinavir/ritonavir (potent UGT1A1/3 inhibitors) have been shown to significantly increase the plasma concentrations of elvitegravir (see Table 2).
Maltese: Pereżempju, intwera li atazanavir/ritonavir u lopinavir/ritonavir (inibituri qawwija ta' UGT1A1/3) iżidu b'mod sinifikanti l-konċentrazzjonijiet ta' elvitegravir fil-plażma (ara Tabella 2).
English: Atazanavir/ritonavir and lopinavir/ritonavir have been shown to significantly increase the plasma concentrations of elvitegravir (see section 4.5).
Maltese: Intwera li atazanavir/ritonavir u lopinavir/ritonavir iżidu b'mod sinifikanti l-konċentrazzjonijiet ta' elvitegravir fil-plażma (ara sezzjoni 4.5).
English: Assessment of adverse reactions is based on data from a controlled clinical study (GS-US-183-0145) in which 712 HIV-1 infected, antiretroviral treatment-experienced adults received elvitegravir (n = 354) or raltegravir (n = 358) each administered with a background regimen consisting of a fully active ritonavir-boosted protease inhibitor and other antiretroviral agents.
Maltese: L-evalwazzjoni ta' reazzjonijiet avversi hi bbażata fuq dejta minn studju kliniku kkontrollat (GS-US-183-0145) li fih 712 adulti infettati bl-HIV-1, li rċivew trattament b'mediċini antiretrovirali fil-passat, irċivew elvitegravir (n = 354) jew raltegravir (n = 358), li kull wieħed ingħata ma' kors flisfond li kien jikkonsisti minn inibitur tal-protease imsaħħaħ b'ritonavir attiv b'mod sħiħ u mediċini antiretrovirali oħrajn.
English: Elvitegravir is 98-99% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1.0 ng/mL to 1.6 µg/mL.
Maltese: Elvitegravir jeħel b'rata ta' 98-99% mal-proteini fil-plażma tal-bniedem u t-twaħħil hu indipendenti mill-konċentrazzjoni tal-mediċina fuq il-medda ta' 1.0 ng/mL sa 1.6 µg/mL.
English: Abacavir (600 mg once daily) Elvitegravir (200 mg once daily) Ritonavir (100 mg once daily)
Maltese: Abacavir (600 mg darba kuljum) Elvitegravir (200 mg darba kuljum)
English: Table 3: Tabulated summary of adverse reactions to elvitegravir based on experience for 96 weeks from clinical study GS-US-183-0145
Maltese: Tabella 3: Sommarju tabulat ta' reazzjonijiet avversi għal elvitegravir ibbażat fuq esperjenza ta' 96 ġimgħa minn studju kliniku GS-US-183-0145
English: Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) and the class of the second agent (NRTI or other classes).
Maltese: L-għażla b'mod każwali ġiet stratifikata bl-iskrinjar tal-livell ta' HIV-1 RNA (≤ 100,000 kopja/mL jew > 100,000 kopja/mL) u l-klassi tat-tieni mediċina (NRTI jew klassijiet oħra).
English: The median terminal plasma half-life of ritonavir-boosted elvitegravir is approximately 8.7 to 13.7 hours.
Maltese: Il-medjan tal-half-life terminali fil-plażma ta' elvitegravir imsaħħaħ b'ritonavir hu ta' madwar 8.7 sa 13.7 sigħat.
English: Elvitegravir (125 mg once daily)
Maltese: Elvitegravir (125 mg darba kuljum)
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX11.
Maltese: Antivirali għal użu sistemiku; antivirali oħrajn, Kodiċi ATC:
English: Virologic success rates at week 96 for elvitegravir and raltegravir were 39.0% (23/59) and 52.2% (35/67) (difference: -8.4% [95% CI: -26.1% to 9.2%]), respectively, for female subjects, and 55.1% (161/292) and 53.2% (151/284) (difference: 1.5% [95% CI: -6.5% to 9.6%]), respectively, for male subjects.
Maltese: 1% sa 9.2%]), rispettivament, għal individwi nisa, u 55.1% (161/292) u 53.2% (151/284) (differenza: 1.5% [95% CI: -6.5% sa 9.6%]), rispettivament, għal individwi rġiel.
English: The absolute oral bioavailability has not been
Maltese: Ilbijodisponibiltà orali assoluta ma ġietx stabbilita.
English: Elvitegravir + background regimen n = 351
Maltese: Elvitegravir + kors fl-isfond n = 351
English: Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation by UGT1A1/3 enzymes (minor route).
Maltese: Elvitegravir jgħaddi minn metaboliżmu ossidattiv minn CYP3A (rotta prinċipali), u glukoronidazzjoni minn enzimi UGT1A1/3 (rotta minuri).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jbatu minn disfunzjoni tal-fwied li tinkludi epatite attiva kronika, għandhom żieda filfrekwenza ta' anormalitajiet tal-fwied waqt it-terapija antiretrovirali kombinata (CART) u jeħtieġ li jiġu monitorjati skond il-prattika normali.
English: Similar rates of raltegravir resistance development occurred in the HIV-1 from subjects treated with raltegravir (26/351 raltegravir-treated subjects, 7.4%).
Maltese: Rati simili ta' żvilupp ta' reżistenza għal raltegravir seħħew fl-HIV-1 minn individwi ttrattati b'raltegravir (26/351 individwu ttrattati b'raltegravir, 7.4%).
English: Elvitegravir is primarily metabolised and eliminated by the liver.
Maltese: Elvitegravir jiġi metabolizzat u eliminat prinċipalment mill-fwied.
English: Relative to fasting conditions, the administration of boosted elvitegravir as the fixed-dose combination 150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/245 mg tenofovir disoproxil with a light meal (approximately 373 kcal, 20% fat) or high-fat meal (approximately 800 kcal, 50% fat) resulted in increased exposures of elvitegravir.
Maltese: Meta mqabbel ma' kundizzjonijiet fl-istat sajjem, l-għoti ta' elvitegravir imsaħħaħ bħala lkombinazzjoni ta' doża fissa ta' 150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/245 mg tenofovir disoproxil ma' ikla ħafifa (madwar 373 kcal, 20% xaħam) jew b'ammont għoli ta' xaħam (madwar 800 kcal, 50% xaħam), irriżulta f'żieda fl-esponimenti ta' elvitegravir.
English: C]elvitegravir, elvitegravir was the predominant species in plasma, representing approximately 94% and 61% of the circulating radioactivity at 32 and 48 hours, respectively.
Maltese: C]elvitegravir imsaħħaħ b'ritonavir, elvitegravir kien lispeċi predominanti fil-plażma, li jirrappreżenta madwar 94% u 61% tar-radjuattività li kienet tiċċirkola wara 32 u 48 siegħa, rispettivament.
English: The following pack size is available: outer cartons containing 1 bottle of 30 film-coated tablets.
Maltese: Id-daqs tal-pakkett li ġej huwa disponibbli: kartun ta' barra li fihom flixkun wieħed ta' 30 pillola
English: In addition, in vitro studies have shown that elvitegravir is a weak to modest inducer of CYP1A2, CYP2C19 and CYP3A enzymes.
Maltese: Flimkien ma' dan, studji in vitro wrew li elvitegravir hu induttur minn dgħajjef sa modest ta' enzimi CYP1A2, CYP2C19 u CYP3A.
English: Raltegravir + background regimen n = 351
Maltese: Raltegravir + kors fl-isfond n = 351
English: Vitekta film-coated tablets are green, triangle-shaped tablets, debossed on one side with “GSI” and “150” on the other side of the tablet.
Maltese: Il-pilloli miksija b'rita ta' Vitekta huma pilloli ħodor, forma ta' trijangolu, b'“GSI” imnaqqxa fuq naħa waħda u n-numru “150” fuq in-naħa l-oħra tal-pillola.
English: Animal studies do not indicate direct or indirect harmful effects of elvitegravir with respect to reproductive toxicity.
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi ta' elvitegravir fuq is-sistema riproduttiva.
English: Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Maltese: Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849 Sverige
English: Due to insufficient clinical data, the combination of elvitegravir with tipranavir is not recommended (see section 4.2).
Maltese: Minħabba dejta insuffiċjenti, ilkombinazzjoni ta' elvitegravir ma' tipranavir mhijiex rakkomandata (ara sezzjoni 4.2).
English: Vitekta contains the active substance elvitegravir.
Maltese: Vitekta fih is-sustanza attiva elvitegravir.
English: If you are also taking an antacid such as aluminium/magnesium hydroxide or calcium carbonate, or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Vitekta.
Maltese: Jekk qed tieħu wkoll antaċidu bħal aluminium/magnesium hydroxide jew calcium carbonate, jew suppliment ta' multivitamini, ħudu mill-inqas 4 sigħat qabel jew mill-inqas 4 sigħat wara Vitekta.
English: Vitekta 85 mg film-coated tablets Elvitegravir
Maltese: Vitekta 85 mg pilloli miksija b'rita Elvitegravir
English: Vitekta film-coated tablets are green, pentagon-shaped tablets, debossed on one side with “GSI” and “85” on the other side of the tablet.
Maltese: Il-pilloli miksija b'rita ta' Vitekta huma pilloli ħodor, forma ta' pentagonu, b'“GSI” imnaqqxa fuq naħa waħda u n-numru “85” fuq in-naħa l-oħra tal-pillola.
English: The BR was selected by the investigator based on genotypic/phenotypic resistance testing and prior antiretroviral treatment history.
Maltese: Il-BR intgħażel mill-investigatur ibbażat fuq ittestjar ta' reżistenza ġenotipika/fenotipika u l-istorja medika ta' trattament antiretrovirali fil-passat.
English: • rifampicin, used to prevent and treat tuberculosis and other infections
Maltese: • rifampicin, jintuża għal prevenzjoni u għal trattament ta' tuberkulosi u infezzjonijiet oħrajn
English: §Due to inhibition of CYP3A by ritonavir, 25-O-desacetyl-rifabutin exposure is increased.
Maltese: Minħabba l-inibizzjoni ta' CYP3A minn ritonavir, lesponiment għal 25-O-desacetylrifabutin jiżdied.
English: In study GS-US-183-0145, subgroup analyses by co-administered protease inhibitor showed similar rates of virologic success for elvitegravir and raltegravir within each protease inhibitor subgroup at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) (Table 6).
Maltese: Fi studju GS-US-183-0145, analiżijiet tas-sottogrupp permezz ta' inibitur tal-protease mogħti flimkien, urew rati simili ta' suċċess viroloġiku għal elvitegravir u raltegravir f'kull sottogrupp ta' inibitur talprotease f'ġimgħat 48 u 96 (HIV-1 RNA ta' inqas minn 50 kopja/mL) (Tabella 6).
English: No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B) (see sections 4.2 and 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Vitekta mhu meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A), jew moderat (Child-Pugh Klassi B) (ara sezzjonijiet 4.2 u 5.2).
English: Frequencies are defined as common (≥ 1/100 to < 1/10) or
Maltese: Il-frekwenzi huma deskritti bħala komuni (≥ 1/100 sa < 1/10) jew mhux komuni (≥ 1/1,000 sa < 1/100).
English: Table 6: Virologic success by co-administered protease inhibitor in study GS-US-183-0145 at week 48 and week 96 (snapshot analysis)
Maltese: Tabella 6: Suċċess viroloġiku permezz ta' inibitur tal-protease mogħti flimkien fi studju GS-US-183-0145 f'ġimgħa 48 u ġimgħa 96 (analiżi snapshot)
English: Elvitegravir does not inhibit human topoisomerases I or II.
Maltese: Elvitegravir ma jinibixxix topoisomerases umani I jew II.
English: The safety and efficacy of elvitegravir in children aged 0 to less than 18 years have not yet been established (see section 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' elvitegravir fit-tfal minn età ta' 0 sa inqas minn 18-il sena ma ġewx determinati s'issa (ara sezzjoni 5.1).
English: • nevirapine
Maltese: • sturdament
English: Hrvatska
Maltese: Frekwenza
English: Table 5: Virologic outcome of randomised treatment of study GS-US-183-0145 at week 48 and week 96 (snapshot analysis)
Maltese: Riżultat viroloġiku ta' trattament magħżul b'mod każwali ta' studju GS-US-183-0145 f'ġimgħa 48 u ġimgħa 96 (analiżi snapshot)