FrancophonIA/ELRC3.0 huggingface dataset:
English: At 96-weeks, in treatment-experienced patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 29 %, 34 % and 13 %, respectively, of co-infected subjects treated with raltegravir as compared to 11 %, 10 % and 9 % of all other subjects treated with raltegravir.
Maltese: F'Ġimgħa 96, f'pazjenti li għaddew minn kura, anormalitajiet tal-laboratorju ta' Grad 2 jew ogħla li jirrappreżentaw Grad agħar mil-linja bażi ta' AST, ALT jew bilirubin totali, seħħew f'29 %, 34 % u 13 %, rispettivamment, tal-individwi ko-infettati kkurati b'raltegravir meta mqabbel ma' 11 %, 10 % u 9 % tal-individwi l-oħrajn kollha kkurati b'raltegravir.
English: Raltegravir has a relatively low genetic barrier to resistance.
Maltese: Raltegravir għandu barriera ġenetika relattivament baxxa għar-reżistenza.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside reverse transcriptase inhibitors.
Maltese: Kien hemm rapporti ta' disfunzjoni mitokondrijali fi trabi negattivi għall-HIV esposti in utero u/jew wara t-twelid għal inibituri ta' reverse transcriptase.
English: Treatment with NRTIs should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Maltese: Il-kura b'NRTIs għandha titwaqqaf meta sseħħ iperlaktejtimja sintomatika u aċidożi lattika/metabolika, epatomegalija progressiva jew meta l-livelli ta' aminotransferase jiżdiedu malajr.
English: Table 2 Efficacy Outcome at Weeks 48 and 96
Maltese: Tabella 2 Eżitu ta' Effikaċja fil-Ġimgħa 48 u 96
English: Mean CD4 cell count (%) increase from baseline
Maltese: Żieda fl-għadd medju ta' ċelloli CD4 (%) mil-linja bażi
English: • Lamivudine belongs to a group of medicines called nucleoside analogue reverse transcriptase
Maltese: • Lamivudine jagħmel parti minn grupp ta' mediċini msejħa inibituri ta' nucleoside analogue
English: Lipid disorders should be managed as clinically appropriate (see section 4.8).
Maltese: Disturbi fil-lipidi għandhom jiġu ġestiti b'mod klinikament xieraq (ara sezzjoni 4.8).
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Maltese: Żieda żgħira f'Cmax (28 %) ġiet osservata meta zidovudine ngħata ma' lamivudine, madankollu lespożizzjoni ġenerali (AUC) ma tinbidilx b'mod sinifikanti.
English: Recommendations are based on available data from the individual components.
Maltese: Ir-rakkomandazzjonijiet huma bbażati fuq id-dejta disponibbli minn komponenti individwali.
English: The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown.
Maltese: Il-mutant M184V RT juri tnaqqis ta'< 4 darbiet fis-suxxettibbiltà tiegħu għal didanosine; l-importanza klinika ta' dawn is-sejbiet mhix magħrufa.
English: DUTREBIS is not recommended for use in combination with emtricitabine containing products, since both lamivudine (in DUTREBIS) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Maltese: DUTREBIS mhuwiex rakkomandat għall-użu flimkien ma' prodotti li fihom emtricitabine, peress li kemm lamivudine (f'DUTREBIS) kif ukoll emtricitabine huma analogi ta' cytidine (jiġifieri riskju għal interazzjonijiet intraċellulari) (ara sezzjoni 4.4).
English: No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies conducted with raltegravir.
Maltese: L-ebda evidenza ta' mutaġeniċità jew ġenotossiċità ma kienet osservata f'testijiet (Ames) ta' mutaġenesi mikrobjali in vitro, assaġġi alkaline elution in vitro għat-tkissir tad-DNA u studji ta' aberrazzjoni tal-kromożomi in vitro u in vivo mwettqa b'raltegravir.
English: No dosage adjustment of DUTREBIS or trimethoprim
Maltese: Mediċini oħra u DUTREBIS
English: There were no clinically important pharmacokinetic differences between patients with severe renal insufficiency
Maltese: Ma kien hemm l-ebda differenza farmakokinetika klinikament importanti bejn pazjenti b'indeboliment renali
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Maltese: Il-metaboliżmu ta' lamivudine ma jinvolvix CYP3A, li għalhekk aktarx ma joħloqx nuqqas ta' qbil ma' prodotti mediċinali metabolizzati b'din is-sistema (eż. PIs).
English: BENCHMRK 1 and BENCHMRK 2 (multi-centre, randomised, double-blind, placebo-controlled studies) evaluated the safety and anti-retroviral activity of raltegravir 400 mg twice daily vs. placebo in a combination with optimized background therapy (OBT), in HIV-infected patients, 16 years or older, with documented resistance to at least 1 medicinal product in each of 3 classes (NRTIs, NNRTIs, PIs) of anti-retroviral therapies.
Maltese: BENCHMRK 1 u BENCHMRK 2 (studji kkontrollati bi plaċebo, double blind, randomizzati, multiċentriċi,) evalwaw is-sigurtà u l-attività antiretrovirali ta' raltegravir 400 mg darbtejn kuljum vs plaċebo f'kombinazzjoni ma' terapija ta' sfond ottimizzata (OBT), f'pazjenti infettati bl-HIV, ta' 16il sena jew aktar, b'reżistenza ddokumentata għal tal-inqas prodott mediċinali f'kull waħda mit3 klassijiet (NRTIs, NNRTIs, PIs) ta' terapiji antiretrovirali.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In Phase III studies with raltegravir, treatment-experienced patients (N = 114/699 or 16 %; HBV=6 %, HCV=9 %, HBV+HCV=1 %) and treatment-naïve patients (N = 34/563 or 6 %; HBV=4 %, HCV=2 %, HBV+HCV=0.2 %) with chronic (but not acute) active hepatitis B and/or hepatitis C co-infection were permitted to enrol provided that baseline liver function tests did not exceed 5 times the upper limit of normal.
Maltese: HBV=4 %, HCV=2 %, HBV+HCV=0.2 %) b'infezzjoni tal-epatite B u/jew l-epatite Ċ attiva kronika (iżda mhux akuta) tħallew jirreġistaw sakemm it-testijiet tal-funzjoni tal-fwied tal-linja bażi ma taqbiżx b'5 darbiet l-ogħla limitu tan-normal.
English: In the second study (n=16), the median cerebrospinal fluid concentration was 3 % (range 1 to 61 %) of the corresponding plasma concentration.
Maltese: Fit-tieni studju (n=16), il-konċentrazzjoni medja tal-fluwidu ċerebrospinali kienet 3 % (medda ta' 1 sa 61 %) tal-konċentrazzjoni fil-plażma korrispondenti.
English: Any child exposed in utero to nucleoside and nucleotide reverse transcriptase inhibitors, even HIV-negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Maltese: Kwalunkwe tarbija esposta in utero għal inibituri ta' reverse transcriptase ta' nukleosidi u nukleotidi, anki trabi negattivi għallHIV, għandhom jiġu segwiti klinikament u fil-laboratorju u jridu jiġu investigati b'mod sħiħ għal disfunzjoni tal-mitokondrija possibbli f'każ ta' sinjali jew sintomi rilevanti.
English: When used with other medicines, DUTREBIS may:
Maltese: Meta jintuża ma' mediċini oħra, DUTREBIS jista':
English: The safety profile observed in patients who used atazanavir and / or tenofovir was generally similar to the safety profile of patients who did not use these agents.
Maltese: Il-profil tas-sigurtà osservat f'pazjenti li użaw atazanavir u/jew tenofovir kien ġeneralment simili għall-profil tas-sigurtà ta' pazjenti li ma użawx dawn l-aġenti.
English: Studies with raltegravir in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji b'raltegravir fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravir (as potassium).
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' lamivudine u 300 mg ta' raltegravir (bħala potassju).
English: In addition, raltegravir inhibited viral replication in cultures of mitogen-activated human peripheral blood mononuclear cells infected with diverse, primary clinical isolates of HIV-1, including isolates from 5 non-B subtypes, and isolates resistant to reverse transcriptase inhibitors and protease inhibitors.
Maltese: Barra minn hekk, raltegravir inibixxa r-replikazzjoni virali f'kulturi ta' ċelloli mononukleari tad-demm periferali talbniedem attivati b'mitoġenu li huma infettati b'diversi iżolati kliniċi primarji ta' HIV-1, inkluż iżolati minn 5 sottotipi mhux B, u iżolati reżistenti għal inibituri ta' reverse transcriptase u inibituri ta' protease.
English: At 240-weeks, in treatment-naïve patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 22 %, 44 % and 17 %, respectively, of co-infected subjects treated with raltegravir as compared to 13 %, 13 % and 5 % of all other subjects treated with raltegravir.
Maltese: F'240 ġimgħa, f'pazjenti li ma esperjenzawx il-kura, anormalitajiet tal-laboratorju ta' Grad 2 jew ogħla li jirrappreżentaw Grad agħar mil-linja bażi ta' AST, ALT jew bilirubin totali, seħħew f'22 %, 44 % u 17 %, rispettivamment, tal-individwi ko-infettati kkurati b'raltegravir meta mqabbel ma' 13 %, 13 % u 5 % tal-individwi l-oħrajn kollha kkurati b'raltegravir.
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Maltese: 9, 4.2, u 3.8 f'kull 100 sena tal-pazjent (PYR), rispettivament; u tar-raxx relatat mal-mediċina kienu 2.4, 1.1 u 2.3 f'kull 100
English: In a comparison of 30 subjects receiving raltegravir with *28/*28 genotype to 27 subjects with wild-type genotype, the geometric mean ratio (90 % CI) of AUC was 1.41 (0.96, 2.09) and the geometric mean ratio of C12 hr was 1.91 (1.43, 2.55).
Maltese: Fi tqabbil ta' 30 individwu li jirċievu raltegravir b'ġenotip *28/*28 ma' 27 individwu b'ġenotip ta' tip salvaġġ, il-proporzjon tal-medja ġeometrika (90 % CI) ta' AUC kien 1.41 (0.96, 2.09) u l-proporzjon tal-medja ġeometrika ta' C12 hr kien 1.91 (1.43, 2.55). Aġġustament fid-doża ma jitqiesx meħtieġ f'individwi b'attività UGT1A1 imnaqqsa minħabba polimorfiżmu ġenetiku.
English: The evidence of efficacy of raltegravir was based on the analyses of 96-week data from two randomised, double-blind, placebo-controlled studies, (BENCHMRK 1 and BENCHMRK 2, Protocols 018 and 019) in antiretroviral treatment-experienced HIV-1 infected adult patients and the analysis of 240-week data from randomised, double-blind, active-control trial, (STARTMRK, Protocol 021) in antiretroviral treatment-naïve HIV-1 infected adult patients.
Maltese: L-evidenza tal-effikaċja ta' raltegravir kienet ibbażata fuq l-analiżijiet tad-dejta ta' Ġimgħa 96 minn żewġ studji kkontrollati bi plaċebo, double-blind, randomizzati, (BENCHMRK 1 u BENCHMRK 2, Protokolli 018 u 019) f'pazjenti adulti infettati bl-HIV-1 li għaddew minn kura antiretrovirali u lanaliżi ta' dejta ta' 240 ġimgħa minn prova b'kontroll attiv, double-blind, randomizzata, (STARTMRK, Protokoll 021) f'pazjenti adulti infettati bl-HIV-1 li ma għaddewx minn kura
English: Although in vitro studies indicated that raltegravir is not an inhibitor of the UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, one clinical study has suggested that some inhibition of UGT1A1 may occur in vivo based on effects observed on bilirubin glucuronidation.
Maltese: Għalkemm studji in vitro jindikaw li raltegravir mhuwiex inibitur tal-glucuronosyltransferases UPD(UGTs) 1A1 u 2B7, studju kliniku wieħed issuġġerixxa li tista' sseħħ xi inibizzjoni ta' UGT1A1 in vivo abbażi tal-effetti osservati fuq bilirubin glucuronidation.
English: Some patients experienced viral rebound between Week 16 and Week 96.
Maltese: Xi pazjenti esperjenzaw rikaduta virali bejn Ġimgħa 16 u Ġimgħa 96.
English: The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.
Maltese: Il-half-life terminali evidenti ta' raltegravir huwa ta' madwar 9 sigħat, b'half-life tal-fażi a iqsar (~ siegħa) li tammonta għall-parti l-kbira tal-AUC.
English: The initial dose finding stage included intensive pharmacokinetic evaluation.
Maltese: L-istadju tas-sejba tad-doża inizjali kien jinkludi evalwazzjoni farmokinetika intensiva.
English: Interaction (mechanism, if known)
Maltese: Interazzjoni (mekkaniżmu, jekk ikun magħruf)
English: • high doses of co-trimoxazole - used to treat infections.
Maltese: • dożi għoljin ta' co-trimoxazole - użati biex jikkuraw infezzjonijiet.
English: For raltegravir, renal clearance of unchanged drug is a minor pathway of elimination.
Maltese: Għal raltegravir, l-eliminazzjoni renali tal-mediċina mhux mibdula huwa passaġġ minuri ta' eliminazzjoni.
English: A median of 4 ARTs was used in OBT.
Maltese: Fl-OBT intuża medjan ta' 4 ARTs.
English: Renal function should be monitored in patients more likely to have decreased renal function.
Maltese: Il-funzjoni renali għandha tiġi sorveljata f'pazjenti li huma aktar probabbli li jkollhom funzjoni renali mnaqqsa.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Ir-reazzjonijiet avversi ewlenin irrapportati huma disturbi ematoloġiċi (anemija, newtropenja), disturbi metaboliċi (iperlaktejtimja, iperlipejżemja).
English: The observed half-life of elimination is 5 to 7 hours.
Maltese: Il-half-life ta' eliminazzjoni osservata ta' lamivudine hija 5 sa 7 sigħat.
English: Pharmacokinetic Interaction Data between the Individual Components of DUTREBIS and
Maltese: Dejta dwar l-Interazzjoni Farmakokinetika bejn il-Komponenti Individwali ta' Dutrebis u
English: Raltegravir is eliminated primarily by glucuronidation in the liver.
Maltese: Raltegravir huwa eliminat primarjament b'glukuronidazzjoni fil-fwied.
English: It contains the active substances lamivudine and raltegravir:
Maltese: Fih is-sustanzi attivi lamivudine and raltegravir:
English: The following data are based on findings in separate studies with the individual components of DUTREBIS (lamivudine and raltegravir).
Maltese: Id-dejta li ġejja hija bbażata fuq is-sejbiet fi studji separati bil-komponenti individwali ta' DUTREBIS (lamivudine u raltegravir).
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Maltese: Dejta in vitro għandha t-tendenza li turi li l-kontinwazzjoni ta' lamivudine f'reġim ta' kura antiretrovirali, minkejja li l-iżvilupp ta' M184V, tista' tipprovdi attività antiretrovirali residwa (li tista' sseħħ minħabba li l-virus ma jibqax jiffunzjona sewwa).
English: In both studies at Week 24, suppression of HIV RNA to less than 50 copies/ml was maintained in 84.4 % of the raltegravir group versus 90.6 % of the lopinavir (+) ritonavir group, (Non-completers = Failure).
Maltese: Fiż-żewġ studji filĠimgħa 24, trażżin ta' RNA tal-HIV għal inqas minn 50 kopja/ml inżamm f'84.4 % tal-grupp ta' raltegravir meta mqabbel ma' 90.6 % tal-grupp ta' lopinavir (+) ritonavir, (Dawk li ma Temmewx=Falliment).
English: In a drug interaction study with DUTREBIS and etravirine, there was no clinically meaningful drug interaction between raltegravir and etravirine, with respect to raltegravir.
Maltese: Fi studju ta' interazzjoni tal-mediċini b'DUTREBIS u etravirine, ma kien hemm ebda interazzjoni klinikament sinifikanti tal-mediċini bejn raltegravir u etravirine, fir-rigward ta' raltegravir.
English: HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Maltese: L-HIV huwa l-virus li jikkawża s-Sindromu ta' Immunodefiċjenza Akkwistata (AIDS - Acquired Immune Deficiency
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Maltese: Dejta limitata turi li lamivudine jidħol fis-sistema nervuża ċentrali u jilħaq il-fluwidu ċerebro-spinali (CSF).
English: Pharmacokinetics in pregnancy
Maltese: .1 Proprjetajiet farmakodinamiċi
English: A slight increase in incidence of supernumerary ribs was observed in rat pups of dams exposed to raltegravir at approximately 4.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr. No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Maltese: Żieda ħafifa fl-inċidenza ta' kustilji supernumerarji kienet osservata fi friegħ ta' firien ta' ommijiet esposti għal raltegravir f'madwar 4.4 drabi l-espożizzjoni tal-bniedem b'400 mg darbtejn kuljum bbażata fuq AUC0-24 hr.
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Maltese: Lamivudine ma kienx ġenotossiku in vivo f'dożi li rriżultaw f'konċentrazzjonijiet fil-plażma 40-50 darba aktar mil-livelli ta' plażma klinika antiċipati.
English: There is limited information regarding the use of lamivudine and raltegravir in the elderly (see section 5.2).
Maltese: Hemm dejta limitata dwar l-użu ta' lamivudine u raltegravir fl-anzjani (ara sezzjoni 5.2).
English: DUTREBIS also helps stop the production of an enzyme called “HIV integrase”.
Maltese: DUTREBIS jista' jgħin ukoll biex iwaqqaf il-produzzjoni ta' enzima msejħa "integrase ta' HIV".
English: Additionally, renal insufficiency was evaluated in the composite pharmacokinetic analysis.
Maltese: Barra minn hekk, il-funzjoni renali ġiet evalwata fl-analiżi farmakokinetika komposta.
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues (see section 4.4).
Maltese: Ġew irrapportati każijiet ta' aċidożi lattika, xi drabi fatali, ġeneralment assoċjati ma' epatomegalija severa u steatożi tal-fwied, bl-użu ta' analogi tan-nukleosidi (ara sezzjoni 4.4).
English: The following adverse reactions were identified through post-marketing surveillance of raltegravir: thrombocytopenia, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness), hepatic failure, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati permezz ta' sorveljanza wara t-tqegħid fis-suq ta' raltegravir: tromboċitopenja, ħsibijiet ta' suwiċidju, imġiba suwiċidali (b'mod partikolari f'pazjenti bi storja medika preċedenti ta' mard psikjatriku), insuffiċjenza epatika, sindromu ta' Stevens Johnson, raxx mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), rabdomijolosi.
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections,
Maltese: Antivirali għall-użu sistemiku; antivirali għall-kura ta' infezzjonijiet, kombinazzjonijiet bl-HIV, kodiċi ATC:
English: Similar AUC values for fed vs. fasted and somewhat lower Cmax values (23 % for raltegravir and 21 % for lamivudine) were observed with DUTREBIS.
Maltese: Kienu osservati valuri AUC simili għal stat sajjem u mitmugħ u valuri Cmax ferm aktar baxxi (23 % għal raltegravir u 21 % għal lamivudine) b'DUTREBIS.
English: Virologic failure and development of resistance
Maltese: Insuffiċjenza viroloġika u żvilupp ta' reżistenza
English: • harsh, raspy, or strained voice; nosebleed; nasal congestion
Maltese: • disfunzjoni erettili; tkabbir tas-sider fl-irġiel; sintomi tal-menopawsa
English: However, the magnitude of the effect seems unlikely to result in clinically important drug-drug interactions.
Maltese: Madankollu, jidher li d-daqs tal-effett mhuwiex probabbli li jirriżulta f'interazzjonijiet importanti bejn il-mediċini.
English: In two studies of HIV-1 infected patients who received raltegravir 400 mg twice daily, raltegravir was readily detected in the cerebrospinal fluid.
Maltese: F'żewġ studji ta' pazjenti infettati bl-HIV-1 li ngħataw raltegravir 400 mg darbtejn kuljum, raltegravir instab malajr fil-fluwidu ċerebrospinali.
English: One patient experienced drug related clinical adverse reactions of Grade 3 psychomotor hyperactivity, abnormal behaviour and insomnia; one patient experienced a Grade 2 serious drug related allergic
Maltese: Pazjent pedjatriku partikolari esperjenza reazzjonijiet avversi kliniċi relatati mal-mediċina ta' iperattività psikomotorja ta' Grad 3, imġiba stramba u insomnja; pazjent partikolari esperjenza raxx allerġiku serju relatat mal-mediċina ta' Grad 2.
English: The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4).
Maltese: L-effett ta' indeboliment epatiku serju fuq il-farmakokinetika ta' raltegravir ma ġiex studjat (ara sezzjonijiet 4.2 u 4.4).
English: DUTREBIS should not be given in patients with a creatinine clearance of <50 ml/min.
Maltese: DUTREBIS m'għandux jingħata f'pazjenti b'eliminazzjoni ta' kreatinina ta' <50 ml/min.
English: Lamivudine in the fixeddose combination tablet was bioequivalent with the lamivudine (single agent) after administration of the individual component.
Maltese: Lamivudine fil-pillola kombinata b'doża fissa kien bijoekwivalenti għal lamivudine (aġent uniku) wara l-għoti tal-komponent individwali.
English: • rifampicin - used to treat some infections such as tuberculosis.
Maltese: • rifampicin - użat biex jikkura xi infezzjonijiet bħat-tuberkulożi.
English: These results indicate that raltegravir is not an inducer or inhibitor of CYP3A4, and raltegravir is thus not anticipated to affect the pharmacokinetics of medicinal products which are CYP3A4 substrates.
Maltese: Dawn ir-riżultati jindikaw li raltegravir mhuwiex induttur jew inibitur ta' CYP3A4, u għalhekk raltegravir mhuwiex mistenni li jaffettwa lfarmakokinetika ta' prodotti mediċinali li huma sottostrati ta' CYP3A4.
English: Standard genotoxicity studies to evaluate mutagenicity and clastogenicity were negative.
Maltese: Studji ġenotossiċi standard biex tiġi evalwata l-mutaġeniċità u lklastoġeniċità kienu negattivi.
English: As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1,600 mg.
Maltese: Kif indikat f'voluntiera b'saħħithom mogħtija dożi orali uniċi ta' raltegravir fi stat sajjem, l-AUC u sCmax ta' raltegravir jiżdiedu b'mod proporzjonali għad-doża fuq il-medda ta' doża ta' 100 mg sa 1,600 mg.
English: Vistor hf.
Maltese: Fih il-lattożju.
English: raltegravir AUC  36 % raltegravir C12hr  21 % raltegravir Cmax  36 %
Maltese: raltegravir C12hr  61 % raltegravir Cmax  38 %
English: The pharmacokinetic properties of lamivudine have been determined in a small group of HIV-1-infected adults with impaired renal function.
Maltese: Il-proprjetajiet farmakokinetiċi ta' lamivudine ġew stabbiliti fi grupp żgħir ta' adulti infettati bl-HIV-1
English: The pharmacokinetics of lamivudine after administration to patients over 65 years of age have not been studied; however, there was no clinically meaningful effect of age on raltegravir pharmacokinetics over the age range studied (19 to 71 years, with few (8) subjects over the age of 65).
Maltese: Il-farmakokinetika ta' lamivudine wara l-għoti lil pazjenti ta' aktar minn 65 sena ma ġietx studjata, madankollu, ma kien hemm l-ebda effett kliniku sinifikanti tal-età fuq il-farmakokinetika ta' raltegravir fuq il-medda ta' etajiet studjati (19 sa 71 sena, bi ftit (8) individwi li kellhom aktar minn 65 sena).
English: People taking anti-retroviral medicines may find that their body shape changes.
Maltese: In-nies li jieħdu mediċini antiretrovirali jistgħu jsibu li l-forma ta' ġisimhom tinbidel.
English: • medicines containing lamivudine - used to treat HIV or hepatitis B.
Maltese: • mediċini li fihom lamivudine - użati biex jikkuraw l-HIV jew l-epatite B