FrancophonIA/ELRC3.0 huggingface dataset:
English: Factors that reduced the likelihood of developing resistance included lower baseline viral load and use of other active anti-retroviral agents.
Maltese: Fatturi li naqqsu l-probabbiltà li tiġi żviluppata reżistenza kienu jinkludu viral load bażika aktar baxxa u l-użu ta' sustanzi antiretrovirali attivi oħra.
English: raltegravir AUC ↑ 37 % raltegravir C12 hr ↑ 24 % raltegravir Cmax ↑ 51 %
Maltese: raltegravir AUC ↑ 37% raltegravir C12-il siegħa ↑ 24% raltegravir Cmax ↑ 51%
English: Administration of raltegravir following a low-fat meal decreased AUC and Cmax by 46 % and 52 %, respectively; C12 hr was essentially unchanged.
Maltese: L-għoti ta' raltegravir wara ikla b'xaħam baxx naqqset l- AUC u Cmax b' 46% u 52%, rispettivament; C12 hr kien essenzjalment mhux mibdul.
English: Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066 (4 weeks to less than 2 years of age)
Maltese: Karatteristiċi tal-Linja Bażi u Riżultati tal-Effikaċja fil-Ġimgħat 24 u 48 minn IMPAACT P1066 (4 ġimgħat għal inqas minn sentejn)
English: Treatment-naïve adult patients (400 mg twice daily) STARTMRK (multi-centre, randomised, double-blind, active-control trial) evaluated the safety and anti-retroviral activity of raltegravir 400 mg twice daily vs. efavirenz 600 mg at bedtime, in a combination with emtricitabine (+) tenofovir disoproxil fumarate, in treatment-naïve HIV-infected patients with HIV RNA > 5,000 copies/mL.
Maltese: Pazjenti adulti li ma rċevewx it-trattament qabel (400 mg darbtejn kuljum) STARTMRK (prova b'aktar minn ċentru wieħed, randomizzata, double-blind, ikkontrollata bissustanza attiva) evalwat is-sigurtà u l-attività antiretrovirali ta' raltegravir 400 mg darbtejn kuljum vs. efavirenz 600 mg fil-ħin tal-irqad, f'kombinazzjoni ma' emtricitabine (+) tenofovir disoproxil fumarate, f'pazjenti infettati bl-HIV li ma rċevewx trattament qabel, li kellhom HIV RNA > 5,000 kopja/mL.
English: How should I store Isentress?
Maltese: Kif għandi naħżen Isentress?
English: Treatment-experienced adult patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Raltegravir 400 mg twice daily + OBT (N = 462)
Maltese: Raltegravir 400 mg darbtejn kuljum + OBT
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-farmakokinetiċi ta' raltegravir ma ġiex studjat (ara sezzjoni 4.2 u 4.4).
English: ISENTRESS 600 mg film-coated tablets raltegravir
Maltese: ISENTRESS 600 mg pilloli miksijin pilloli raltegravir
English: The dosing recommendations are based on approximately: 1.5 mg/kg/dose.
Maltese: 1.5 mg/kg/doża.
English: What Isentress is
Maltese: Isentress.
English: The other ingredients are: hydroxypropyl cellulose, sucralose, saccharin sodium , sodium citrate dihydrate, mannitol, red iron oxide, yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E420), fructose, natural and artificial flavours (orange, banana, and masking), aspartame (E951), crospovidone Type A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, and macrogol/PEG 400.
Maltese: Is-sustanzi mhux attivi l-oħra huma: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate dihydrate, mannitol, red iron oxide, yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E420), fructose, benniet naturali u artifiċjali (larinġ, banana, u masking), aspartame (E951), crospovidone Tip A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, u macrogol/PEG 400.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew b'diffikultajiet fl-assorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: In IMPAACT P1110 (see section 5.2) eligible infants were at least 37 weeks gestation and at least 2 kg in weight.
Maltese: F'IMPAACT P1110 (ara sezzjoni 5.2), it-trabi eleġibbli kienu tal-inqas 37 ġimgħa ġestazzjoni u talinqas 2 kg fil-piż.
English: Refer to the 400 mg tablet and granules for oral suspension SmPCs for additional dosing information.
Maltese: Irreferi għall-SmPCs tal-pillola ta' 400 mg u tal-granuli għal sospensjoni orali għal informazzjoni addizzjonali dwar id-dożaġġ.
English: No dose adjustment required for raltegravir or tenofovir disoproxil fumarate.
Maltese: emtricitabine u tenofovir disoproxil fumarate
English: Uncommon anaemia, iron deficiency anaemia, lymph node pain, lymphadenopathy, neutropenia, thrombocytopenia
Maltese: Mhux komuni anemija, anemija minħabba nuqqas ta' ħadid, uġigħ fin-nodi limfatiċi, limfadenopatija, newtropenija, tromboċitopenja
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir in mice, rats, dogs and rabbits.
Maltese: Saru studji tossikoloġiċi li mhumiex kliniċi inkluż studji konvenzjonali tal-farmakoloġija tas-sigurtà, tossiċità ta' doża ripetuta, ġenotossiċità, tossiċità tal-iżvilupp, u effett tossiku fuq iż-żgħażagħ, b'raltegravir fuq ġrieden, firien, klieb u fniek.
English: Randomisation was stratified by screening HIV RNA level (≤ 100,000 copies/mL; and > 100,000 copies/mL) and by hepatitis B or C status (positive or negative).
Maltese: Ir-randomizzazzjoni ġiet stratifikata bil-livell tal-HIV RNA fl-iskrining (≤100,000 kopja/mL; u > 100,000 kopja/mL) u bl istatus tal-epatite B jew Ċ (pożittiv jew negattiv).
English: etravirine AUC  10 % etravirine C12hr  17 % etravirine Cmax  4 %
Maltese: (Induzzjoni ta' UGT1A1) etravirine AUC ↑ 10% etravirine C12hr ↑ 17% etravirine Cmax ↑ 4%
English: etravirine AUC  10% etravirine C12hr  17% etravirine Cmax  4%
Maltese: (induzzjoni ta' UGT1A1) etravirine AUC ↑ 10% etravirine C12hr ↑ 17% etravirine Cmax ↑ 4%
English: While the magnitudes of change on raltegravir exposure from raltegravir 400 mg twice daily by ritonavir, boceprevir or etravirine were small, the impact from tipranavir/ritonavir was greater (GMR Ctrough=0.45, GMR AUC=0.76).
Maltese: Filwaqt li d-daqs tal bidla fuq l-esponiment ta' raltegravir minn raltegravir 400 mg darbtejn kuljum minn ritonavir, boceprevir jew etravirine kien wieħed żgħir, l-impatt minn tipranavir/ritonavir kien akbar (GMR Ctrough=0.
English: Achieved HIV RNA <50 copies/mL Mean CD4 cell count (%) increase from baseline
Maltese: Kisbu HIV RNA ta' <50 kopja/mL Żieda medja fl-għadd ta' ċelloli CD4 (%) mil-linja bażi
English: ISENTRESS 25 mg chewable tablets raltegravir
Maltese: ISENTRESS 25 mg pilloli li tomgħodhom raltegravir
English: Recommended Dose for ISENTRESS For Oral Suspension in Full-Term Neonates (Birth to 4 weeks [28 days] of age*
Maltese: Doża Rakkomandata għal ISENTRESS Għal Sospensjoni Orali fi Trabi tat-Twelid ta' Terminu Sħiħ (Twelid sa età ta' 4 ġimgħat [28 jum]*
English: As a general rule, it is recommended that mothers infected by HIV do not breast-feed their babies in order to avoid transmission of HIV.
Maltese: Bħala regola ġenerali, huwa rrakkomandat li ommijiet infettati bl-HIV ma jreddgħux lit-trabi tagħhom sabiex jevitaw it-trażmissjoni tal-HIV.
English: The rates of discontinuation of raltegravir due to adverse reactions were 5% or less in clinical trials.
Maltese: Ir-rati ta' twaqqif ta' raltegravir minħabba reazzjonijiet avversi kienu 5 % jew inqas fil-provi kliniċi.
English: The other ingredients are: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate dihydrate, mannitol, yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E420), fructose, natural and artificial flavours (orange, banana, and masking), aspartame (E951), crospovidone Type A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP and macrogol/PEG 400.
Maltese: L-ingredjenti l-oħra huma: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate dihydrate, mannitol, yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E420), fructose, togħma naturali u artifiċjali (larinġ, banana, u masking), aspartame (E951), crospovidone Tip A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP u macrogol/PEG 400.
English: MSD Danmark ApS Tlf: +45 4482 4000 dkmail@merck.com
Maltese: Tlf: +45 4482 4000
English: Isentress is also available in a 400 mg tablet, a 600 mg tablet and in a chewable tablet.
Maltese: Isentress huwa disponibbli wkoll f'pillola ta' 400 mg, f'pillola ta' 600 mg u f'pillola li tomgħodha.
English: Carcinogenicity
Maltese: ANTIMIKROBIĊI
English: In this study, administration of the chewable tablet with a high fat meal led to an average 6 % decrease in AUC, 62 % decrease in Cmax, and 188 % increase in C12hr compared to administration in the fasted state.
Maltese: F'dan l-istudju, l-għoti tal-pillola li tomgħodha ma' ikla b'kontenut għoli ta' xaħam wassal għal tnaqqis medju ta' 6% fl-AUC, tnaqqis ta' 62% fis-Cmax, u żieda ta' 188% fis-C12hr meta mqabbel mal-għoti fuq stonku vojt.
English: 2 blue (10 mL) syringes
Maltese: 2 siringi blu (ta' 10 mL)
English: etravirine (raltegravir 400 mg Twice Daily)
Maltese: Etravirine (raltegravir 400 mg Darbtejn Kuljum)
English: No dosage adjustment required for raltegravir or hormonal contraceptives (estrogenand/or progesterone-based).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal raltegravir jew tal kontraċettivi orali (bażati fuq estroġen u/jew progesterone)
English: emtricitabine and tenofovir disoproxil fumarate (raltegravir 1,200 mg (2 x 600 mg) Once Daily)
Maltese: boceprevir jew etravirine ma' raltegravir 1,200 mg (2 x 600 mg) darba kuljum.
English: One pack size is available: 1 carton with 60 sachets, two 10 mL syringes, two 3 mL syringes, two 1 mL syringes, two mixing cups, this package leaflet and booklet with instructions for use.
Maltese: Pakkett wieħed huwa disponibbli: 1 kartuna b'60 qartas, żewġ siringi ta' 10 mL, żewġ siringi ta' 3 mL, żewġ siringi ta' 1 mL, żewġ tazzi tar-rikostituzzjoni, dan il-fuljett ta' tagħrif u ktejjeb b'istruzzjonijiet għall-użu.
English: BENCHMRK 1 and BENCHMRK 2 (multi-centre, randomised, double-blind, placebo-controlled trials) evaluated the safety and anti-retroviral activity of raltegravir 400 mg twice daily vs. placebo in a combination with optimised background therapy (OBT), in HIV-infected patients, 16 years or older, with documented resistance to at least 1 drug in each of 3 classes (NRTIs, NNRTIs, PIs) of anti-retroviral therapies.
Maltese: BENCHMRK 1 u BENCHMRK 2 (provi multi-ċentri, randomizzati, double-blind, ikkontrollati bilplaċebo) jevalwaw 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' 16-il sena jew akbar, b'reżistenza iddokumentata għal mill-anqas mediċina waħda minn kull waħda minn 3 klassijiet (NRTIs, NNRTIs, PIs) ta' terapiji antiretrovirali.
English: Uncommon cachexia, diabetes mellitus, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hyperphagia, increased appetite, polydipsia, body fat disorder
Maltese: Mhux komuni tnaqqis fl-aptit kaxeksja, dijabete mellitus, dislipidemija, iperkolesterolemja, ipergliċemija, iperlipidemija, iperfaġja, żieda fl-aptit, polidipsja, disturb fixxaħam tal-ġisem
English: For patients weighing at least 25 kg but are unable to swallow a tablet, consider the chewable tablet.
Maltese: Għal pazjenti li jiżnu inqas minn 25 kg iżda li mhumiex kapaċi jibilgħu pillola, ikkunsidra l-pillola li tomgħodha.
English: Isentress 600 mg film-coated tablets is used to treat adults and paediatric patients weighing at least 40 kg who are infected by HIV.
Maltese: Isentress 600 mg pilloli miksija b'rita jintuża għat-trattament ta' persuni adulti u pazjenti pedjatriċi li jiżnu talanqas 40 kg li huma infettati bl-HIV.
English: The chewable tablets and the granules for oral suspension have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Maltese: Il-pilloli li tomgħodhom ma ġewx studjati f'adoloxxenti (12 sa 18-il sena) jew adulti infettati bl-HIV.
English: Cohort 1 (N=16, 10 exposed and 6 unexposed to raltegravir in utero) received 2 single doses of raltegravir GFS (within 48 hours and 7 - 10 days after birth); Cohort 2 (N=26, all raltegravir unexposed in utero) received raltegravir GFS for 6 weeks: 1.5 mg/kg once daily starting within 48 hours of birth through Week 1; 3 mg/kg twice daily Weeks 2 to 4; and 6 mg/kg twice daily Weeks 5 and 6.
Maltese: Koorti 1 (N=16,10 esposti u 6 mhux esposti għal raltegravir fl-utru) irċivew 2 dożi waħidhom ta' raltegravir GFS (fi żmien 48 siegħa mit-twelid u 7 - 10 ijiem wara t-twelid);Koorti 2 (N=26, kollha mhux estposti għal raltegravir fl-utru) irċivew raltegravir GFS għal 6 ġimgħat:
English: Co-administration of raltegravir with antacids containing divalent metal cations may reduce raltegravir absorption by chelation, resulting in a decrease of raltegravir plasma levels.
Maltese: L-għoti flimkien ta' raltegravir ma' antaċidi li fihom cations tal-metall divalenti jista' jnaqqas lassorbiment ta' raltegravir permezz ta' ‘chelation', u dan jirriżulta fi tnaqqis fil-livelli tal-plasma ta' raltegravir.
English: Overall, considerable variability was observed in the pharmacokinetics of raltegravir.
Maltese: B'mod ġenerali, kienet osservata varjabilità konsiderevoli fil-farmakokinetiċi ta' raltegravir.
English: Neonates, Infants and Toddlers
Maltese: Età (sigħat/jiem) mal-Kampjunar
English: Uncommon arthralgia, arthritis, back pain, flank pain, musculoskeletal pain, myalgia, neck pain, osteopenia, pain in extremity, tendonitis, rhabdomyolysis
Maltese: Mhux komuni artralġja, artrite, uġigħ fid-dahar, uġigħ mal-ġnub, uġigħ muskoluskeletriku, uġigħ fil-muskoli, uġigħ fl-għonq, osteopenja, uġigħ fl-estremitajiet, tendonite, rabdomijolisi
English: Response
Maltese: ANTAĊIDI
English: Patients with rare hereditary problems of fructose intolerance glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: • Keep the bottle tightly closed, with the desiccant in order to protect from moisture.
Maltese: *Tliet pazjenti ma komplewx minħabba nuqqas ta' konformità.
English: Each film-coated tablet contains 400 mg of raltegravir (as potassium).
Maltese: Kull pillola fiha 400 mg ta' raltegravir (bħala potassju).
English: Each chewable tablet contains approximately 0.46 mg fructose, approximately 0.05 mg phenylalanine (as a component of aspartame) and approximately 1.4 mg sorbitol.
Maltese: Kull pillola li tomgħodha fiha madwar 0.46 mg fructose, madwar 0.05 mg phenylalanine (bħala komponent ta' aspartame) u madwar 2.8 mg sorbitol.
English: Children at least 11 kg: weight based dose of the chewable tablet to a maximum dose of 300 mg, twice daily as specified in Tables 1 and 2.
Maltese: Tfal ta' mill-inqas 11 kg, doża abbażi tal-piż tal-pillola li tomgħodha sa doża massima ta' 300 mg, darbtejn kuljum kif speċifikat f'Tabella 1 u 2.
English: raltegravir AUC  14% raltegravir C24hr  6% raltegravir Cmax  9%
Maltese: raltegravir C24hr ↓ 6% raltegravir Cmax ↓ 9%
English: Table 6
Maltese: Tabella 3
English: Renal impairment No dosage adjustment is required for patients with renal impairment (see section 5.2).
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: There were no clinically important pharmacokinetic differences due to gender, race, ethnicity or body weight in adults for raltegravir 400 mg twice daily, and no clinically meaningful effect on raltegravir pharmacokinetics was concluded.
Maltese: Ma kien hemm ebda differenzi farmakokinetiċi klinikament importanti minħabba s-sess, razza etniċità jew il-piż tal-ġisem f'adulti għal raltegravir 400 mg darbtejn kuljum, u ebda effett klinikament sinifikanti fuq farmakokinetiċi ta' raltegravir ma kienx konkluż.
English: For raltegravir 1,200 mg (2 x 600 mg) once daily, population PK analysis also demonstrated that the impacts of gender, race, ethnicity and body weight are not clinically meaningful.
Maltese: Għal raltegravir 1,200 mg (2 x 600 mg) darba kuljum, l-analiżi tal-popolazzjoni ta' PK ukoll uriet li l-impatt fuq is-sess, razza, etnicità u l-piż tal-ġsem mhumiex klinikament sinifikanti.
English: • harsh, raspy, or strained voice; nosebleed; nasal congestion
Maltese: • impotenza; tkabbir fis-sider fl-irġiel; sintomi ta' menopawża
English: • 2 mixing cups
Maltese: • 2 tazez tar-rikostituzzjoni
English: Uncommon alanine aminotransferase increased, atypical lymphocytes, aspartate aminotransferase increased, blood triglycerides increased, lipase increased, blood pancreatic amylase increased absolute neutrophil count decreased, alkaline phosphatase increased, blood albumin decreased, blood amylase increased, blood bilirubin increased, blood cholesterol increased, blood creatinine increased, blood glucose increased, blood urea nitrogen increased, creatine phosphokinase increased, fasting blood glucose increased, glucose urine present, high density lipoprotein increased, international normalised ratio increased, low density lipoprotein increased, platelet count decreased, red blood cells urine positive, waist circumference increased, weight increased, white blood cell count decreased
Maltese: Mhux komuni żieda f'alanine aminotransferase, limfoċiti atipiċi, żieda f'aspartate aminotransferase, żieda taltrigliċeridi fid-demm, żieda fil-lipase, żieda flamylase tal-frixa fid-demm tnaqqis fl-għadd ta' newtrofili assoluti, żieda flalkaline phosphatase, tnaqqis fl-albumina fiddemm, żieda tal-amylase fid-demm, żieda filbilirubina fid-demm, żieda tal-kolesterol fid-demm, żieda tal-kreatinina fid-demm, żieda taz-zokkor fiddemm, żieda tan-nitroġenu fl-urea fid-demm, żieda fil-creatine phosphokinase, żieda fil-glukosju fiddemm waqt is-sawm, glukosju fl-awrina preżenti, żieda fil-lipoproteina ta' densità għolja, żieda filproporzjon normalizzat internazzjonali, żieda fillipoproteina ta' densità baxxa, l-għadd ta' plejtlits imnaqqsa, pożittiv għal ċelluli ħomor tad-demm flawrina, żieda fiċ-ċirkonferenza tal-qadd, żieda filpiż, l-għadd ta' ċelluli bojod tad-demm imnaqqsa
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: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja serja fiż-żmien tal-bidu ta' terapija antiretrovirali ikkumbinata (CART), tista' sseħħ reazzjoni infjammatorja għal patoġeni opportunisti asintomatiċi jew residwali u din tista' tikkaġuna kondizzjonijiet kliniċi serji, jew aggravament ta' sintomi.
English: Frequencies are defined as common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: Isentress 100 mg granules for oral suspension raltegravir
Maltese: ISENTRESS 100 mg granuli għal sospensjoni orali raltegravir
English: Each film-coated tablet contains 600 mg of raltegravir (as potassium).
Maltese: Kull pillola fiha 600 mg ta' raltegravir (bħala potassju).
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 patients treated with raltegravir as compared to 11 %, 10 % and 9 % of all other patients treated with raltegravir.
Maltese: Mas-96 ġimgħa fil-pazjenti li diġà kienu rċevew it-trattament, anormalitajiet tal-laboratorju ta' Grad 2 jew ogħla li jirrappreżentaw Grad ta' taħżin mil-linja bażi tal-AST, ALT jew bilirubina totali seħħew f'29%, 34% u 13%, rispettivament, tal-pazjenti infettati fl-istess ħin ittrattati b' raltegravir meta mqabbla ma' 11%, 10% u 9% tal-pazjenti l-oħra kollha ttrattati b' raltegravir.
English: Therefore, no dose adjustment is required with use of proton pump inhibitors or H2 antagonists.
Maltese: H2 BLOCKERS u PROTON PUMP INHIBITORS
English: Each chewable tablet contains 25 mg of raltegravir (as potassium).
Maltese: Kull pillola fiha 25 mg ta' raltegravir (bħala potassju).
English: The evidence of efficacy of raltegravir was based on the analyses of 96-week data from two randomised, double-blind, placebo-controlled trials (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-analiżi tad-dejta ta' 96 ġimgħa minn żewġ provi randomizzati, double-blind, ikkontrollati bil-plaċebo (BENCHMRK 1 u BENCHMRK 2, Protokolli 018 u 019) fuq pazjenti adulti infettati bl-HIV-1 li diġà rċevew trattament antiretrovirali qabel u l-analiżi tad-dejta ta' 240 ġimgħa minn prova randomizzata, double blind, ikkontrollata bissustanza attiva (STARTMRK, Protokoll 021) fuq pazjenti adulti infettati bl-HIV-1 li ma rċevewx trattament antiretrovirali qabel.
English: raltegravir AUC ↑ 44 % raltegravir C12 hr ↑ 6 % raltegravir Cmax ↑ 60 %
Maltese: raltegravir C12 hr ↑ 6% raltegravir Cmax ↑ 60%
English: Table 9 displays pharmacokinetic parameters for neonates in Cohort 2 at birth and at 2 weeks of age.
Maltese: Tabella 9 turi l-parametri farmakokinetiċi għat-trabi tat-twelid f'Koorti 2 mat-twelid u f'età ta' ġimagħtejn.
English: Uncommon vertigo tinnitus
Maltese: Jekk tinsa tieħu Isentress
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL 196 (174, 219) 192 (169, 214) ≤ 100,000 copies/mL 180 (160, 200) 134 (115, 153) CD4-count ≤ 50 cells/mm > 50 and ≤ 200 cells/mm > 200 cells/mm Viral Subtype Clade B Non-Clade B
Maltese: HIV-RNA > 100,000 kopja/mL 126 (107, 144) ≤ 100,000 kopja/mL Għadd ta' CD4 ≤ 50 ċellola/mm3 121 (100, 142) > 50 u ≤ 200 ċellola/mm3 > 200 ċellola/mm3
English: • trouble sleeping; abnormal dreams; nightmare; abnormal behaviour; feelings of deep sadness and unworthiness
Maltese: • problemi biex torqod; ħolm abnormali; ħmar il-lejl, komportament mhux normali; sentimenti ta'
English: Randomisation was stratified by screening HIV RNA level (≤ 50,000 copies/mL; and > 50,000 copies/mL) and by hepatitis B or C status (positive or negative).
Maltese: Ir-randomizzazzjoni ġiet stratifikata bil-livell tal-HIV RNA fl-iskrining (≤ 50,000 kopja/mL; u > 50,000 kopja/mL) u bl-istatus tal-epatite B jew Ċ (pożittiv jew negattiv).
English: With respect to the primary efficacy endpoint, the proportion of patients achieving HIV RNA < 50 copies/mL at Week 48 was 241/280 (86.1 %) in the group receiving raltegravir and 230/281 (81.9 %) in the group receiving efavirenz.
Maltese: Rigward l-iskop primarju finali tal-effikaċja, il-proporzjon ta' pazjenti li kisbu RNA ta' HIV < 50 kopja/mL f'Ġimgħa 48 kien ta' 241/280 (86.1%) fil-grupp li kien qed jirċievi raltegravir u ta' 230/281 (81.9%) fil-grupp li kien qed jirċievi efavirenz.
English: For details on preparation and administration of the suspension, see section 6.6.
Maltese: Għal dettalji dwar il-preparazzjoni u l-għoti tas-sospensjoni, ara sezzjoni 6.6.