FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine/tenofovir disaproxil fumarate was identified to increase raltegravir 1,200 mg once daily bioavailability by 12%, however its impact is not clinically meaningful.
Maltese: Emtricitabine/tenofovir disaproxil fumarate ġie identifikat li jżid il-biodisponibbiltà ta' raltegravir 1,200 mg darba kuljum bi 12%, madankollu l-impatt tiegħu mhuwiex klinikament sinifikanti.
English: Yellow, oval-shaped, dimensions 19.1 mm x 9.7 mm x 6.1 mm, marked with MSD corporate logo and “242” on one side and plain on the other side.
Maltese: Pillola safra, ovali, b'dimensjonijiet 19.1 mm x 9.7 mm x 6.1 mm, immarkata bil-logo korporattiv ta'
English: Table 9: Raltegravir Pharmacokinetic Parameters IMPAACT P1110 Following Age and Weight Based Dosing of the Granules for Suspension
Maltese: Tabella 9: Parametri Farmakokinetiċi ta' Raltegravir IMPAACT P1110 Wara Dożaġġ talGranuli għal Sospensjoni Bbażat fuq l-Età u l-Piż
English: Myopathy and rhabdomyolysis have been reported.
Maltese: Mijopatija u rabdomijolisi ġew irrapportati.
English: ISENTRESS is also available in a chewable tablet formulation and in granules for oral suspension formulation.
Maltese: ISENTRESS huwa disponibbli wkoll f'formulazzjoni ta' pillola li tomgħodha u fi granuli f'formulazzjoni ta' sospensjoni.
English: Birth - 48 hours
Maltese: seconds - 45 sekonda)
English: This neoplasia could result from local deposition and/or aspiration of drug on the mucosa of the nose/nasopharynx during oral gavage dosing and subsequent chronic irritation and inflammation; it is likely that it is of limited relevance for the intended clinical use.
Maltese: Din in-neoplasija tista' tirriżulta minn depożizzjoni lokali u/jew aspriazzjoni ta' mediċina fuq il-mukoża tal-imnieħer/nasofarinġite matul dożaġġ gavagali orali u irritazzjoni u infjammazzjoni kronika sussegwenti; huwa probabbli li hija ta' relevanza limitata għallużu kliniku maħsub.
English: EU/1/07/436/001 EU/1/07/436/002 180 film-coated tablets (3 bottles of 60)
Maltese: EU/1/07/436/002 180 pillola miksija b'rita (3 fliexken ta' 60)
English: Isentress granules for oral suspension contain fructose, sorbitol and sucrose If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Maltese: Isentress granuli għal sospensjoni orali fihom il-fructose, sorbitol u sucrose Jekk it-tabib tiegħek qallek li għandek intolleranza għal xi zokkor, kellem lit-tabib tiegħek qabel tieħu din il-mediċina.
English: The treatment difference (raltegravir 1,200 mg once daily-raltegravir 400 mg twice daily) was 0.5 % with an associated 95 % CI of (-4.2, 5.2) establishing that raltegravir 1,200 mg once daily is non-inferior to raltegravir 400 mg twice daily.
Maltese: Id-differenza fil-kura (raltegravir 1,200 mg darba kuljum - raltegravir 400 mg darbtejn kuljum) kienet ta' 0.5 % b'95 % CI assoċjat ta' (-4.2, 5.2) li jistabbilixxi li raltegravir 1,200 mg darba kuljum huwa ‘mhux inferjuri' għal raltegravir 400 mg darbtejn kuljum.
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 rash.
Maltese: Pazjent wieħed esperjenza reazzjonijiet avversi kliniċi relatati mal-mediċina ta' attività psikomotorja eċċessiva, imġiba mhux normali u nuqqas ta' rqad, ta' Grad 3; pazjent wieħed esperjenza raxx allerġiku serju relatat mal-mediċina, ta' Grad 2.
English: EU/1/07/436/006 EU/1/07/436/007 180 film-coated tablets (3 bottles of 60)
Maltese: EU/1/07/436/007 180 pillola miksija b'rita (3 fliexken ta' 60)
English: Table 1 Pharmacokinetic Interaction Data
Maltese: Tabella 1 Tagħrif dwar l-Interazzjonijiet Farmakokinetika
English: The absolute bioavailability of raltegravir has not been established.
Maltese: Il-bijodisponibbilità assoluta ta' raltegravir ma ġietx stabbilita.
English: Raltegravir twice daily has been studied in 126 antiretroviral treatment-experienced HIV-1 infected children and adolescents 2 to 18 years of age, in combination with other antiretroviral agents in IMPAACT P1066 (see sections 5.1 and 5.2).
Maltese: Raltegravir ġie studjat f'126 tifel/tifla u adolexxent/a ta' bejn 2 u 18-il sena, infettati bl-HIV-1, li kienu rċevew trattament antiretrovirali qabel, f'kombinazzjoni ma' sustanzi antiretrovirali oħra f'IMPAACT P1066 (ara sezzjonijiet 5.1 u 5.2).
English: Each single-use sachet contains 100 mg of raltegravir which is to be suspended in 10 mL of water giving a final concentration of 10 mg per mL (see section 6.6).
Maltese: Kull pakkett ta' użu wieħed ta' sospensjoni orali fih 100 mg ta' raltegravir li huwa sospiż f'10 mL ilma li jagħti konċentrazzjoni finali ta' 10 mg/mL (ara sezzjoni 6.6).
English: Kit Contents
Maltese: Kontenut tal-Kitt
English: Some patients experienced viral rebound between Week 16 and Week 96.
Maltese: Xi pazjenti esperjenzaw rebound virali bejn Ġimgħa 16 u Ġimgħa 96.
English: Two pack sizes are available: packs containing1 bottle with 60 tablets, and multipacks comprising 3 bottles, each containing 60 tablets.
Maltese: Hemm disponibbli żewġ daqsijiet ta' pakkett: pakketti li fihom flixkun b'60 pillola, u pakketti multipli li fihom 3 fliexken, kull wieħed fih 60 pillola.
English: Comprehensive drug interaction studies were performed with raltegravir 400 mg twice daily and a limited number of drug interaction studies were performed for raltegravir 1,200 mg once daily.
Maltese: Studji komprensivi ta' interazzjoni tal-mediċini twettqu b'raltegravir 400 mg darbtejn kuljum u numru limitat ta' studji ta' interazzjoni tal-mediċina twettqu għal raltegravir 1,200 mg darba kuljum.
English: Uncommon abdominal distention, abdominal pain, diarrhoea, flatulence, nausea, vomiting, dyspepsia gastritis, abdominal discomfort, abdominal pain upper, abdominal tenderness, anorectal discomfort, constipation, dry mouth, epigastric discomfort, erosive duodenitis, eructation, gastroesophageal reflux disease, gingivitis, glossitis, odynophagia, pancreatitis acute, peptic ulcer, rectal haemorrhage
Maltese: Mhux komuni distensjoni addominali, uġigħ addominali, dijarea, gass, tqalligħ, rimettar, dispepsja gastrite, skumdità addominali, uġigħ addominali fin-naħa ta' fuq, sensittività addominali, skumdità anorettali, stitikezza, ħalq xott, skumdità epigastrika, duwodenite erusiva, tifwieq, mard ta' rifluss gastroesofageali, ġinġivite, glossite, odinofaġja, pankreatite ulċera fl-istonku akuta, ulċera fl-istonku, emorraġija fir-rektum
English: Note: Make sure your doctor shows you how to prepare and give Isentress for oral suspension.
Maltese: Nota: Kun ċert li t-tabib tiegħek jurik kif tipprepara u tagħti Isentress għal sospensjoni orali.
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 provokatur jew inibitur ta' CYP3A4, u għalhekk raltegravir mhuwiex mistenni li jaffettwa l-farmakokinetiċi ta' prodotti mediċinali li huma sottostrati ta' CYP3A4.
English: MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
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 medjana fil-fluwidu tal-moħħ u ssinsla kienet ta' 3% (medda minn 1 sa 61%) tal-konċentrazzjoni korrispondenti fil-plażma.
English: Co-administration of raltegravir 1,200 mg once daily and tipranavir/ritonavir is not recommended.
Maltese: L-għoti flimkien ta' raltegravir 1,200 mg darba kuljum u tipranavir/ritonavir mhuwiex rakkomandat.
English: The other ingredients are: microcrystalline cellulose, hypromellose 2910, croscarmellose sodium and magnesium stearate.
Maltese: Is-sustanzi mhux attivi l-oħra huma: microcrystalline cellulose, hypromellose 2910, croscarmellose sodium u magnesium stearate.
English: (Mechanism of interaction unknown)
Maltese: (mekkaniżmu ta' interazzjoni mhux magħruf)
English: At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was similar to that at the clinical dose of 400 mg twice daily.
Maltese: Flogħla livelli tad-doża, 400 mg/kg/kuljum fin-nisa u 250 mg/kg/kuljum fl-irġiel, l-esponiment sistemiku kien simili għal dak fid-doża klinika ta' 400 mg darbtejn kuljum.
English: A slight increase in incidence of supernumerary ribs, a variant in the normal developmental process, was observed in rat foetuses 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.
Maltese: Żieda żgħira fl-inċidenza ta' kustilji supernumerarji, varjant fil-proċess ta' żvilupp normali kienet osservata f'feti ta' firien nisa esposti għal raltegravir f'madwar 4.4 drabi l-espożizzjoni umana f'400 mg darbtejn kuljum fuq il-bażi ta' AUC0-24 hr.
English: HIV-1 Exposed Neonates
Maltese: Perċentwali HIV-RNA
English: At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was similar to that at the clinical dose of 1,200 mg once daily.
Maltese: Flogħla livelli tad-doża, 400 mg/kg/kuljum fin-nisa u 250 mg/kg/kuljum fl-irġiel, l-esponiment sistemiku kien simili għal dak fid-doża klinika ta' 1,200 mg darba kuljum.
English: Isentress might interact with other medicines.
Maltese: Isentress jista' jinteraġixxi ma' mediċini oħra.
English: ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection (see sections 4.2, 4.4, 5.1 and 5.2).
Maltese: ISENTRESS huwa indikat f'kombinazzjoni ma' prodotti mediċinali anti-retrovirali oħra għattrattament ta' infezzjoni bil-virus tal-immunodefiċjenza tal-bniedem (HIV-1) (ara sezzjonijiet 4.2, 4.4,
English: Raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1,600 mg. Raltegravir C12 hr increases dose proportionally over the dose range of 100 to 800 mg and increases slightly less than dose proportionally over the dose range 100 mg to 1,600 mg.
Maltese: Is-C12 hr ta' raltegravir tiżdied proporzjonalment fuq il-firxa tad-doża 100 mg sa 800 mg u tiżdied xi ftit anqas mid-doża proporzjonalment fuq il-firxa tad-doża 100 mg sa 1600 mg.
English: Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with the recommended dose of raltegravir.
Maltese: Provokaturi inqas qawwija (eż. efavirenz, nevirapine, etravirine, rifabutin, glukocortikojdi, St.
English: Patients received either the 400 mg tablet formulation (6 to 18 years of age) or the chewable tablet formulation (2 to less than 12 years of age).
Maltese: Il-pazjenti rċevew jew il-formulazzjoni tal-pillola ta' 400 mg (6 sa 18-il sena) jew il-formulazzjoni tal-pillola li tomgħodha (2 sa inqas minn 12-il sena).
English: Renal and urinary disorders Uncommon renal failure, nephritis, nephrolithiasis, nocturia, renal cyst, renal impairment, tubulointerstitial nephritis
Maltese: Mhux komuni insuffiċjenza tal-kliewi, nefrite interstizzjali, nefrolitijasi, nokturja, ċesta renali, indeboliment renali, nefrite tubulointerstizjali
English: 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: 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: Non-completer is failure imputation: patients who discontinued prematurely are imputed as failure thereafter.
Maltese: Pazjent li ma jtemmx it-trattament huwa imputazzjoni ta' falliment: il-pazjenti li waqfu qabel iż-żmien huma imputati bħala falliment wara.
English: In rats, tumours (squamous cell carcinoma) of the nose/nasopharynx were identified at 300 and 600 mg/kg/day in females and at 300 mg/kg/day in males.
Maltese: Fil-firien, ġew identifikati tumuri (karċinoma taċ-ċelloli skwamużi) tal-imnieħer/nasofarinġi fi 300 u 600 mg/kg/kuljum fin-nisa u fi 300 mg/kg/kuljum fl-irġiel.
English: Recommended Dose* for ISENTRESS Granules For Oral Suspension and Chewable Tablets in Paediatric Patients at least 4 weeks of age and weighing 3 to 25 kg
Maltese: Tabella 1: Doża Rakkomandata* għal ISENTRESS Granuli għal Sospensjoni Orali u Pilloli li Tomgħodhom f'Pazjenti Pedjatriċi mill-inqas ta' età ta' 4 ġimgħat u li jiżnu 3 sa 25 kg
English: Caution is recommended when co-administering raltegravir 1,200 mg once daily with sensitive OAT1 and/or OAT3 substrates.
Maltese: Hija rakkomandata l-kawtela meta raltegravir 1,200 mg darba kuljum jingħata flimkien ma' substrati sensittivi ta' OAT1 u/jew OAT3.
English: In a comparison of 30 subjects 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 suġġett b'ġenotip *28/*28 ma' 27 suġġett b'ġenotip ta' tip selvaġġ, il-proporzjon talmedja 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 mhuwiex meqjus neċessarju f'suġġetti b'attività UGT1A1 imnaqqsa minħabba polimorfiżmu ġenetiku.
English: Uncommon mental disorder, suicide attempt, anxiety, confusional state, depressed mood, major depression, middle insomnia, mood altered, panic attack, sleep disorder, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness)
Maltese: Mhux komuni disturb mentali, tentattivi ta' suwiċidju, ansjetà, stat konfużjonali, burdata depressa, depressjoni, dipressjoni maġġuri, insomnija tan-nofs, tibdil filburdata, attakk ta' paniku, disturbi fl-irqad, ħsibijiet ta' suwiċidju, komportament ta' suwiċidju (b'mod partikulari f'pazjenti li diġà jkollhom storja ta' mard psikjatriku)
English: Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23
English: Caution should be used when co-administering raltegravir with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e.g., rifampicin).
Maltese: Għandha tintuża attenzjoni meta raltegravir jingħata fl-istess ħin ma' provokaturi qawwija ta' uridine diphosphate glucuronosyltransferase (UGT) 1A1 (eż.
English: Uncommon skin papilloma
Maltese: Mhux komuni papilloma fil-ġilda
English: Uncommon immune reconstitution syndrome, drug hypersensitivity, hypersensitivity
Maltese: Mhux komuni sindrome tar-rikostituzzjoni immuni,sensittività eċċessiva għal mediċina, sensittività eċċessiva
English: Body weight Formulation
Maltese: Piż tal-ġisem Formulazzjoni
English: Raltegravir 600 mg (1,200 mg once daily)
Maltese: raltegravir 1,200 mg (2 x 600 mg) darba kuljum.
English: ISENTRESS is also available in a chewable tablet formulation and in granules for oral suspension formulation Refer to the chewable tablet and granules for oral suspension SmPCs for additional dosing information.
Maltese: ISENTRESS huwa disponibbli wkoll fil-formulazzjoni ta' pillola li tomgħodha u fi granuli għal formolazzjoni ta' sospensjoni orali.
English: Raltegravir 600 mg tablets (2 x 600 mg once daily) may be administered with or without food.
Maltese: Raltegravir 600 mg pilloli (2 x 600 mg darba kuljum) jista' jingħata mal-ikel jew mingħajru.
English: The other ingredients are: hydroxypropyl cellulose, sucralose, mannitol, monoammonium glycyrrhizinate, sorbitol (E420), fructose, banana flavour, sucrose, crospovidone Type A, magnesium stearate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, macrogol/PEG 400, microcrystalline cellulose and carmellose sodium.
Maltese: Is-sustanzi mhux attivi l-oħra huma: hydroxypropyl cellulose, sucralose, mannitol, monoammonium glycyrrhizinate, sorbitol (E420), fructose, banana flavour, sucrose, crospovidone Tip A, magnesium stearate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, macrogol/PEG 400, microcrystalline cellulose u carmellose sodium.
English: Children and adolescents 2 to 18 years of age
Maltese: Tfal u adolexxenti minn 2 sa 18-il sena
English: vomiting; indigestion; belching
Maltese: rimettar; indiġestjoni; tifwiq
English: Adverse reactions Raltegravir (alone or in combination with other ART)
Maltese: Reazzjonijiet avversi Raltegravir (waħdu jew f'kombinazzjoni ma' ART oħra)
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, 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 and the analysis of 96-week data from randomised, double-blind, active-control trial (ONCEMRK, Protocol 292) 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, 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 u l-analiżi ta' dejta ta' 96 ġimgħa minn prova randomizzata, double blind, ikkontrollata bis-sustanza attiva (ONCEMARK Protokoll 292) f'pazjenti adulti infettati bl-HIV1 li ma rċevewx trattament antiretrovirali.
English: ISENTRESS 100 mg granules for oral suspension
Maltese: ISENTRESS 100 mg granuli għal sospensjoni orali
English: Posology
Maltese: omeprazole
English: Co-administration of raltegravir with a calcium carbonate antacid decreased raltegravir plasma levels; however, this interaction is not considered clinically meaningful.
Maltese: L-għoti flimkien ta' raltegravir ma' antaċidu tal-calcium carbonate naqqas il-livelli tal-plasma ta' raltegravir; madankollu, din l-interazzjoni mhijiex meqjusa bħala li tagħmel sens mil-lat kliniku.
English: All interaction studies were performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti.
English: No dosage adjustment required for raltegravir (400 mg twice daily and 1,200 mg once daily) or hormonal contraceptives (estrogen- and/or progesterone-based).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal raltegravir (400 mg darbtejn kuljum u 1,200 mg darba kuljum) jew kontraċettivi ormonali (ibbażati fuq estroġen u/jew progesterone).
English: • NEW Directions for dose preparation
Maltese: • Direzzjonijiet ĠODDA għall-preparazzjoni tad-doża
English: Uncommon visual impairment
Maltese: Mhux komuni indeboliment fil-vista
English: Raltegravir Pharmacokinetic Parameters IMPAACT P1066 Following Administration of Doses in Section 4.2
Maltese: Tabella 8: Parametri Farmakokinetiċi ta' Raltegravir IMPAACT P1066 Wara l-Għoti tad-Dożi f'Sezzjoni 4.2
English: In treatment-naïve patients, the clinical study data on use of raltegravir are limited to use in combination with two nucleotide reverse transcriptase inhibitors (NRTIs) (emtricitabine and tenofovir disoproxil fumarate).
Maltese: F'pazjenti li qatt ma ħadu dik il-kura qabel, l-informazzjoni mill-istudji kliniċi dwar l-użu ta' raltegravir hija limitata għall-użu f'kombinazzjoni ma' żewġ inibituri nucleotide reverse transcriptase (NRTIs) (emtricitabine u tenofovir disoproxil fumarate).
English: Film-coated tablet
Maltese: Żewġ pilloli darba kuljum
English: With respect to the primary efficacy endpoint, the proportion of patients achieving HIV RNA < 40 copies/mL at Week 48 was 472/531(88.9 %) in the group receiving raltegravir 1,200 mg once daily and 235/266 (88.3 %) in the group receiving raltegravir 400 mg twice daily.
Maltese: Rigward l-iskop primarju finali tal-effikaċja, il-proporzjon ta' pazjenti li kisbu RNA ta' HIV < 40 kopja/mL f'Ġimgħa 48 kien ta' 472/531 (88.9 %) fil-grupp li kien qed jirċievi raltegravir 1,200 mg darba kuljum u ta' 235/2866 (88.3 %) fil-grupp li kien qed jirċievi raltegravir 400 mg darbtejn kuljum.
English: Geometric mean (%CV AUC0-12hr (μM●hr)
Maltese: AUC0-12hr (μM●sigħat)
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
Maltese: Ir-rati ta' raxx aġġustati skont l-esponiment (kienet x'kienet il-kawża) kienu ta' 10.9, 4.2, u 3.8 għal kull 100 sena ta' pazjent (PYR - patientyears), rispettivament; u għal raxx marbut mal-mediċina kienu ta' 2.4, 1.1, u 2.3 għal kull 100
English: 500 cells/mm
Maltese: 500 ċellola/mm3
English: Table 8 displays pharmacokinetic parameters in the 400 mg tablet, the chewable tablet, and the granules for oral suspension, by body weight.
Maltese: Tabella 8 turi l-parametri farmakokinetiċi fil-pillola ta' 400 mg, il-pillola li tomgħodha, u l-granuli għal sospensjoni orali, skont il-piż tal-ġisem.
English: Other medicines and Isentress
Maltese: Mediċini oħra u Isentress
English: Liver problems
Maltese: Problemi fil-ġilda
English: Antacids
Maltese: Naddaf
English: Table 4 Efficacy Outcome at Weeks 48 and 96
Maltese: Analiżi tar-riżultati ta' Ġimgħa 48 u 96
English: In a single-cycle infection assay, raltegravir inhibited infection of 23 HIV isolates representing 5 non-B subtypes and 5 circulating recombinant forms with IC50 values ranging from 5 to 12 nM.
Maltese: F'assaġġ ta' infezzjoni b'ċiklu wieħed, raltegravir impedixxa l-infezzjoni ta' 23 iżolat tal-HIV li jirrappreżentaw 5 sottotipi mhux B u ħames forom rikombinanti ċirkolatorji b'valuri IC50 li jvarjaw minn 5 sa 12 nM.
English: The dosing recommendations are based on approximately: 3 mg/kg/dose.
Maltese: 3 mg/kg/doża.
English: • rifampicin (a medicine used to treat some infections such as tuberculosis), as it may decrease your levels of Isentress.
Maltese: • rifampicin (mediċina użata biex jiġu ttrattati xi infezzjonijiet bħat-tuberkulożi) minħabba li dan jista' jnaqqas il-livelli tiegħek ta' Isentress.
English: ISENTRESS is also available in a 400 mg tablet for use in adults, adolescents and children weighing at least 25 kg and able to swallow a tablet.
Maltese: ISENTRESS huwa disponibbli wkoll f'pillola ta' 400 mg għall-użu f'persuni adulti, adolexxenti u tfal li jiżnu mill-inqas 25 kg u li kapaċi jibilgħu pillola.
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 patients treated with raltegravir as compared to 13 %, 13 % and 5 % of all other patients treated with raltegravir.
Maltese: Mal-240 ġimgħa filpazjenti li ma kinux irċevew it-trattament qabel, anormalitajiet tal-laboratorju ta' Grad 2 jew ogħla li jirrappreżentaw Grad ta' taħżin mil-linja bażi tal-AST, ALT jew bilirubina totali seħħew fi 22%, 44% u 17%, rispettivament, tal-pazjenti infettati fl-istess ħin ittrattati b' raltegravir, meta mqabbla ma' 13%, 13% u 5% tal-pazjenti l-oħra kollha ttrattati b'raltegravir.