FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of the chewable tablet with a high fat meal does not affect raltegravir pharmacokinetics to a clinically meaningful degree and the chewable tablet can be administered without regard to food.
Maltese: Fl-adulti, ma kien hemm l-ebda differenza farmakokinetika klinikament importanti bejn pazjenti b'indeboliment epatiku serju u suġġetti f'saħħithom.
English: Table 6 displays pharmacokinetic parameters in the 400 mg tablet, the chewable tablet, and the granules for oral suspension, by body weight.
Maltese: Tabella 6 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: Excipients with known effect 25 mg
Maltese: Eċċipjenti b'effett magħruf ta' 25mg
English: Two pack sizes are available: 1 bottle with 60 tablets, and a multipack containing 180 (3 bottles of 60) tablets.
Maltese: Jeżistu żewġ daqsijiet tal-pakkett: flixkun b'60 pillola, u pakkett multiplu li fih 180 (3 fliexken ta' 60)
English: For each of the following clinical adverse reactions there was at least one serious occurrence: genital herpes, anaemia, immune reconstitution syndrome, depression, mental disorder, suicide attempt, gastritis, hepatitis, renal failure, accidental overdose.
Maltese: Għal kull waħda minn dawn ir-reazzjonijiet avversi kliniċi li ġejjin kien hemm mill-inqas darba fejn lokkorrenza kienet serja: erpete ġenitali, anemija, sindrome ta' rikostituzzjoni immuni, depressjoni, disturb mentali, attentat ta' suwiċidju, gastrite, epatite, insuffiċjenza tal-kliewi, doża eċċessiva aċċidentali.
English: Percent HIV-RNA < 400 copies/mL (95 % CI) All patients Baseline Characteristic HIV-RNA > 100,000 copies/mL ≤ 100,000 copies/mL CD4-count ≤ 50 cells/mm > 50 and ≤ 200 cells/mm > 200 cells/mm Sensitivity score (GSS)
Maltese: HIV-RNA > 100,000 kopja/mL 62 (53, 69) ≤ 100,000 kopja/mL Għadd ta' CD4 ≤ 50 ċellola/mm3 > 50 u ≤ 200 ċellola/mm3 > 200 ċellola/mm3 Punteġġ tas-sensittività (GSS) §
English: It is unknown whether raltegravir/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk raltegravir/ metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Unit dose sachet for ISENTRESS 100 mg granules for oral suspension - foil sachet
Maltese: Ż-ŻGĦAR EWLENIN Qartas ta' doża waħda għal ISENTRESS 100 mg granuli għal sospensjoni orali - qartas tal-fojl
English: raltegravir AUC  49% raltegravir C12hr  3% raltegravir Cmax ↑ 64%
Maltese: raltegravir C12hr ↑3% raltegravir Cmax ↑64%
English: raltegravir AUC  49 % raltegravir C12hr  3 % raltegravir Cmax ↑ 64 %
Maltese: raltegravir C12hr ↑ 3% raltegravir Cmax ↑ 64%
English: • infection of the hair roots; influenza; skin infection due to virus; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; lymph node abscess
Maltese: • infezzjoni fl-għerq tax-xagħar; influwenza; infezzjoni fil-ġilda minħabba virus; rimettar jew dijarea minħabba sustanza infettiva; infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju; axxess fil-glandoli tal-limfa • felula
English: • Isentress granules for oral suspension are not recommended in pregnancy because they have not been studied in pregnant women.
Maltese: • Isentress granuli għal sospensjoni orali mhumiex rakkomandati waqt it-tqala minħabba li ma ġewx studjati f'nisa tqal.
English: There was no clinically meaningful effect of age on raltegravir pharmacokinetics in healthy subjects and patients with HIV-1 infection over the age range studied (19 to 84 years, with few individuals over the age of 65).
Maltese: Ma kien hemm l-ebda effett kliniku sinifikanti tal-età fuq il-farmakokinetiċi ta' raltegravir f'suġġetti b'saħħithom u f'pazjenti b'infezzjoni tal-HIV-1, fuq il-medda ta' etajiet studjata (19 sa 84 sena, bi ftit individwi li kellhom aktar minn 65 sena).
English: ≤ 100,000 copies/mL CD4 count ≤ 200 cells/mm > 200 cells/mm Viral Subtype Clade B Non-Clade B 233 (205, 261)
Maltese: Sottotip Virali Clade B Mhux Clade B B 233 (205, 261)
English: raltegravir AUC  55% raltegravir C12 hr  32% raltegravir Cmax  52%
Maltese: raltegravir C12 hr ↓ 32% raltegravir Cmax ↓ 52%
English: • liver failure
Maltese: • tnaqqis fl-aptit
English: raltegravir AUC  67% raltegravir C24hr  26% raltegravir Cmax  16%
Maltese: raltegravir C24hr ↑ 26% raltegravir Cmax ↑ 16%
English: Chewable tablet 100 mg - Hydroxypropyl cellulose - Sucralose - Saccharin sodium - Sodium citrate dihydrate - Mannitol - Monoammonium glycyrrhizinate - Sorbitol (E420) - Fructose - Banana flavour - Orange flavour - Masking flavour - Aspartame (E951) - Crospovidone, Type A - Sodium stearyl fumarate- Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Red iron oxide - Yellow iron oxide
Maltese: - Banana flavour - Orange flavour - Masking flavour - Aspartame (E951) - Crospovidone, Tip A - Sodium stearyl fumarate- Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Red iron oxide - Yellow iron oxide
English: Table 2 Efficacy Outcome at Weeks 48 and 96
Maltese: Tabella 2 Riżultati tal-Effikaċja f'Ġimgħat 48 u 96
English: raltegravir AUC  72% raltegravir C24 hr  48% raltegravir Cmax  74%
Maltese: raltegravir C24 hr ↓ 48% raltegravir Cmax ↓ 74%
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL ≤ 100,000 copies/mL CD4-count ≤ 50 cells/mm > 50 and ≤ 200 cells/mm > 200 cells/mm Viral Subtype Clade B Non-Clade B
Maltese: Għadd ta' CD4 ≤ 50 ċellola/mm3 > 50 u ≤ 200 ċellola/mm3 > 200 ċellola/mm3 Sottotip Virali Clade B Non-Clade B
English: raltegravir AUC  40% raltegravir C12hr  61% raltegravir Cmax  38%
Maltese: raltegravir C12hr ↓61% raltegravir Cmax ↓38%
English: raltegravir AUC  40 % raltegravir C12hr  61 % raltegravir Cmax  38 %
Maltese: raltegravir C12hr ↓ 61% raltegravir Cmax ↓ 38%
English: Raltegravir C12 hr was 66 % higher and Cmax was 5 % higher following a moderate-fat meal compared to fasting.
Maltese: Raltegravir C12-il siegħa kien 66% ogħla u Cmax was 5% ogħla wara ikla b'xaħam moderat imqabbla ma' stonku vojt.
English: Excipient with known effect Each tablet contains 26.06 mg lactose (as monohydrate).
Maltese: 06 mg lactose (bħala monohydrate).
English: If it is less than 10 mL, put the tip back into the water and pull back on the plunger until you get to the 10 mL mark.
Maltese: Jekk ikun inqas minn 10 mL, erġa' poġġi t-tarf fl-ilma u iġbed lura fuq ilplanġer sakemm tasal sal-marka ta' 10 mL.
English: Raltegravir Pharmacokinetic Parameters IMPAACT P1066 Following Administration of Doses in Section 4.2 (excluding neonates)
Maltese: Parametri Farmakokinetiċi ta' Raltegravir IMPAACT P1066 Wara l-Għoti tad-Dożi f'Sezzjoni 4.2 (minbarra trabi tat-twelid)
English: Uncommon dizziness, headache, psychomotor hyperactivity amnesia, carpal tunnel syndrome, cognitive disorder, disturbance in attention, dizziness postural, dysgeusia, hypersomnia, hypoaesthesia, lethargy, memory impairment, migraine, neuropathy peripheral, paraesthesia, somnolence, tension headache, tremor, poor quality sleep
Maltese: Mhux komuni amnesija, sindromu tal-mini karpali, disturb konjittiv, disturbi fl-attenzjoni, sturdament minħabba l-pożizzjoni, tibdil fis-sens tat-togħma, ipersomnija, ipoestesja, sfinit, indeboliment filmemorja, emigranja, newropatija periferali, paraestesija, ngħas, uġigħ minħabba tensjoni, rogħda, irqad mhux ta' kwalità tajba
English: raltegravir AUC  49% raltegravir C12 hr  63% raltegravir Cmax  44%
Maltese: raltegravir C12 hr ↓ 63% raltegravir Cmax ↓ 44%
English: • chest discomfort; chills; swelling of face; feeling jittery; generally feeling unwell; neck mass; swelling of hands, ankles or feet; pain
Maltese: • problemi biex torqod; ħolm abnormali; ħmar il-lejl; komportament mhux normali; sentimenti ta'
English: • feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
Maltese: • tħossok ansjuż; tħossok konfuż; burdata depressa; tibdil fil-burdata; attakk ta' paniku
English: Mental health problems
Maltese: Problemi ta' saħħa mentali
English: Refer to the chewable tablet and granules for oral suspension SmPCs for additional dosing information.
Maltese: Irreferi għall-SmPCs tal-pillola li tomgħodha u granuli għal sospensjoni orali għal informazzjoni addizzjonali dwar id-dożaġġ.
English: Achieved ≥1 log10 HIV RNA drop from baseline or <400 copies/mL
Maltese: Perċentwali HIV-RNA < 40 kopja/mL
English: Tel: + 385 1 6611 333 croatia_info@merck.com
Maltese: Tel: 8007 4433 (+356 99917558) malta_info@merck.com
English: Norelgestromin (raltegravir 400 mg Twice Daily)
Maltese: Maraviroc (raltegravir 400 mg Darbtejn Kuljum)
English: Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32 % of the dose was excreted in faeces and urine, respectively.
Maltese: Wara l-għoti ta' doża orali ta' raltegravir radjutikkettat, madwar 51 sa 32% tad-doża ġiet eliminata fl-ippurgar u fl-awrina, rispettivament.
English: raltegravir AUC  4 % raltegravir C12hr  25 % raltegravir Cmax  11 %
Maltese: raltegravir C12hr ↓ 25% raltegravir Cmax ↑ 11%
English: raltegravir AUC  24% raltegravir C12hr  55% raltegravir Cmax  18%
Maltese: raltegravir C12hr ↓55% raltegravir Cmax ↓18%
English: raltegravir AUC  24 % raltegravir C12hr  55 % raltegravir Cmax  18 %
Maltese: raltegravir C12hr ↓ 55% raltegravir Cmax ↓ 18%
English: Pale orange coloured, oval shaped, chewable tablet scored on both sides with the MSD corporate logo and "477" on one side and without inscription on the other side.
Maltese: Ta' lewn oranġjo ċar, għamla ovali, b'sinjal imnaqqax fuq iż-żewġ naħat bil-logo korporattiv ta' MSD u "477" fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: Based on in vitro and in vivo studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway.
Maltese: Fuq il-bażi ta' studji in vitro u in vivo, raltegravir huwa eliminat prinċipalment permezz ta' metaboliżmu minn ġo mogħdija ta' glukuronidazzjoni mwettqa minn UGT1A1.
English: ISENTRESS 25 mg chewable tablets ISENTRESS 100 mg chewable tablets
Maltese: ISENTRESS 25 mg pilloli li tomgħodhom
English: Administration of multiple doses of raltegravir following a moderate-fat meal did not affect raltegravir AUC to a clinically meaningful degree with an increase of 13 % relative to fasting.
Maltese: L-għoti ta' dożi multipli ta' raltegravir wara ikla b'xaħam modern,ma affettwax ir-raltegravir AUC għal grad klinikament elokwenti b'żieda ta' 13% b'mod relattiv għal stonku vojt.
English: • herpes infections including shingles
Maltese: • infezzjonijiet tal-erpete, inkluż ħruq ta' Sant'Antnin
English: Raltegravir inhibits the catalytic activity of integrase, an HIV-encoded enzyme that is required for viral replication.
Maltese: Raltegravir jimpedixxi l-attività katalitika ta' integrase, enzima kkodifikata tal-HIV li hija meħtieġa għar-replikazzjoni virali.
English: One carton contains 60 sachets, two 1 mL, two 3 mL and two 10 mL oral dosing syringes and 2 mixing cups.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 qartas, żewġ siringi tad-dożaġġ orali ta' 1 mL, tnejn ta' 3 mL u tnejn ta' 10 mL u 2 tazez tarrikostituzzjoni.
English: IMPAACT P1066 is a Phase I/II open label multicenter trial to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of raltegravir in HIV infected children.
Maltese: I/II biex tevalwa lprofil farmakokinetiku, is-sigurtà, it-tollerabbiltà, u l-effikaċja ta' raltegravir fi tfal infettati bl-HIV.
English: Final dose population N=96
Maltese: N=96
English: raltegravir AUC  36 % raltegravir C12hr  21 % raltegravir Cmax  36 %
Maltese: raltegravir C12hr ↓21% raltegravir Cmax ↓36%
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL ≤ 100,000 copies/mL CD4-count ≤ 50 cells/mm > 50 and ≤ 200 cells/mm > 200 cells/mm Sensitivity score (GSS)
Maltese: ≤ 100,000 kopja/mL Għadd ta' CD4 ≤ 50 ċellola/mm3 > 50 u ≤ 200 ċellola/mm3 > 200 ċellola/mm3 Punteġġ tas-sensittività (GSS)
English: The safety and efficacy of raltegravir in preterm (<37 weeks of gestation) and low birth weight (<2000 g) newborns have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' raltegravir fi trabi tat-twelid (<37 ġimgħa ta' ġestazzjoni) u piż tat-twelid baxx (<2,000 g) ma ġewx determinati.
English: Push the plunger into the barrel of the syringe as far as it goes.
Maltese: Kun ċert li inti u t-tifel/tifla tiegħek lesti!
English: Percent of patients with response and associated 95 % confidence interval (CI) are reported.
Maltese: Huma rrappurtati l-perċentwali ta' pazjenti b'rispons u intervall ta' kunfidenza (CI) relatat ta' 95%. ‡
English: A moderate amount of data on pregnant women (between 300 - 1,000 pregnancy outcomes from first trimester exposure) indicate no malformative or feto/neonatal toxicity of raltegravir 400 mg twice daily.
Maltese: Ammont moderat ta' dejta f'nisa tqal (bejn 300 - 1,000 riżultat tat-tqala minn esponiment fl-ewwel trimestru) ma jindika l-ebda tossiċità malformattiva jew tal-fetu/neonatali ta' raltegravir 400 mg darbtejn kuljum.
English: No specific information is available on the treatment of overdose with raltegravir.
Maltese: Ma hemm l-ebda informazzjoni speċifika disponibbli fuq it-trattament ta' doża eċċessiva b'raltegravir.
English: Read the package leaflet and booklet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: The chewable tablets are available in 25 mg and scored 100 mg strengths.
Maltese: 25 mg u ta' 100 mg b'sinjal minfejn taqsam il-pillola.
English: Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23 % of the dose, respectively.
Maltese: Żewġ komponenti, jiġifieri raltegravir u raltegravirglucuronide, instabu fl-awrina u kkontribwixxew għal madwar 9 u 23% tad-doża, rispettivament.
English: 3 to less than 4 2.5 mL (25 mg) twice daily 4 to less than 6 3 mL (30 mg) twice daily 6 to less than 8 4 mL (40 mg) twice daily 8 to less than 11 6 mL (60 mg) twice daily 11 to less than 14
Maltese: 1.5 mg/kg darba kuljum li beda fi żmien 48 siegħa mit-twelid sa Ġimgħa 1; 3 mg/kg darbtejn kuljum f'Ġimgħat 2 sa 4; u 6 mg/kg darbtejn kuljum Ġimgħat 5 sa 6.
English: Film-coated tablet.
Maltese: raltegravir fil-plażma.
English: Refer to the 600 mg Summary of Product Characteristics for additional dosing information.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' 600 mg għal informazzjoni addizzjonali dwar id-dożaġġ.
English: raltegravir AUC  37 % raltegravir C12hr  28 % raltegravir Cmax  33 %
Maltese: raltegravir C12hr ↓ 28% raltegravir Cmax ↓ 33%
English: • loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; loss of feeling, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
Maltese: • telf tal-memorja; uġigħ fl-idejn minħabba li n-nervi kkompressaw; disturbi fl-attenzjoni; sturdament bi bdil ta' spiss fil-qagħda; tibdil fis-sens tat-togħma; żieda fl-irqad, nuqqas ta' enerġija; tinsa malajr; emigranja; telf tas-sensibilità; tnemnim jew tħossok debboli f'dirgħajk jew f'riġlejk; ngħas; uġigħ ta' ras minħabba tensjoni; rogħda; irqad mhux ta' kwalità tajba
English: Demographics Age (weeks), median [range] Male Gender Race Caucasian Black Baseline Characteristics Plasma HIV-1 RNA (log10 copies/mL), mean [range] CD4 cell count (cells/mm
Maltese: Kawkasi Suwed Karatteristiċi fil-Linja Bażi HIV-1 RNA fil-plażma (log10 kopji/mL), medja [medda] Għadd ta' ċelloli CD4 (ċelloli/mm3), medjan [medda] Perċentwali ta' CD4, medjan [medda] HIV-1 RNA >100,000 kopja/mL CDC
English: Isentress is also available in a 600 mg tablet, a chewable tablet and in granules for oral suspension.
Maltese: Isentress huwa disponibbli wkoll f'pillola ta' 600 mg, f'pillola li tomgħodha u fi granuli għal sospensjoni orali.
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 the recommended human dose (RHD) based on AUC0-24 hr. No development effects were seen at 3.4-fold human exposure at the RHD.
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 biddoża rakkomandata fil-bniedem (RHD) fuq il-bażi ta' AUC0-24 hr.
English: Chewable tablet 100 mg
Maltese: Pillola li tomgħodha ta' 100 mg
English: Prior ART Use by Class NNRTI PI Response
Maltese: Poġġi kollox ġo post nadif u niexef.
English: Refer to the chewable tablet SmPC for additional dosing information.
Maltese: Irreferi għall-SmPC għall-pilloli li tomgħodha għal informazzjoni addizzjonali dwar id-dożaġġ.
English: ISENTRESS 100 mg chewable tablets
Maltese: ISENTRESS 100 mg pilloli li tomgħodhom
English: - Hydroxypropyl cellulose - Sucralose - Mannitol - Monoammonium glycyrrhizinate - Sorbitol (E420) - Fructose - Banana flavour - Sucrose - Crospovidone, Type A - Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Microcrystalline cellulose - Carmellose sodium
Maltese: - Togħma ta' banana - Togħma ta' laring - Togħma ta' masking - Aspartame (E951) - Crospovidone, Type A - Sodium stearyl fumarate - Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Yellow iron oxide
English: • certain kinds of rash (more often when used in combination with darunavir)
Maltese: • ċerti tipi ta' raxx (aktar spiss meta użat flimkien ma' darunavir);
English: Following reconstitution the oral suspension has a concentration of 10 mg per mL.
Maltese: Wara rikostituzzjoni, is-suspensjoni orali għandha konċentrazzjoni ta' 10 mg għal kull mL.
English: Each single-use sachet of granules for oral suspension contains 100 mg of raltegravir (as potassium).
Maltese: Kull qartas għal użu ta' darba ta' granuli għal sospensjoni orali fih 100 mg ta' raltegravir (bħala potassium).
English: • anaemia including due to low iron
Maltese: • anemija, inkluż minħabba livelli baxxi ta' ħadid
English: Considerable inter- and intra-individual variability was observed in the pharmacokinetics of raltegravir.
Maltese: Ġiet osservata varjabilità konsiderevoli bejn persuni differenti u fl-istess persuna fil-farmakokinetiċi ta' raltegravir.
English: 1 sachet of Isentress granules
Maltese: Kif jaħdem Isentress
English: The orange-banana flavoured chewable tablet is oval-shaped, pale orange coloured, scored on both sides with the MSD corporate logo and "477" on one side and without inscription on the other side.
Maltese: Il-pillola li tomgħodha togħma ta' larinġ-banana għandha għamla ovali, b'sinjal imnaqqax fuq iż-żewġ naħat bil-logo korporattiv ta' MSD u "477" fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: Based on these data, proton pump inhibitors and H2 blockers may be co-administered with raltegravir 1,200 mg once daily.
Maltese: Ibbażat fuq dan it-tagħrif, inibituri tal-pompa tal-protons u impedituri tal-H2 jistgħu jingħataw ma' raltegravir 1,200 mg darba kuljum.
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL ≤ 100,000 copies/mL CD4-count ≤ 50 cells/mm
Maltese: HIV-RNA > 100,000 kopja/mL 196 (174, ≤ 100,000 kopja/mL
English: Co-administration of raltegravir 1,200 mg once daily with tipranavir/ritonavir could result in decreased raltegravir trough plasma levels; therefore, co-administration is not recommended (see section 4.5).
Maltese: L-għoti flimkien ta' raltegravir 1,200 mg darba kuljum ma' tipranavir/ritonavir jista' jirriżulta f'nuqqas ta' raltegravir permezz tal livelli plażma; b'hekk, l-għoti flimkien mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Co-administration of raltegravir with aluminium and magnesium antacids resulted in reduced raltegravir plasma levels.
Maltese: antaċidu tal-aluminium u magnesium hydroxide
English: METAL CATION ANTACIDS aluminium and magnesium hydroxide antacid (raltegravir 400 mg Twice Daily)
Maltese: Ebda aġġustament fid-doża ma huwa meħtieġ għal raltegravir (400 mg darbtejn kuljum).
English: Blood and lymphatic system disorders
Maltese: Tenofovir disoproxil fumarate
English: • spinning sensation
Maltese: Punteġġ tas-sensittività
English: Isentress is also available in a 400 mg tablet, a chewable tablet and in granules for oral suspension.
Maltese: Isentress huwa disponibbli wkoll f'pillola ta' 400 mg, f'pillola li tomgħodha u fi granuli għal sospensjoni orali.
English: Rebounder
Maltese: BAJDA
English: Because the formulations have different pharmacokinetic profiles neither the chewable tablets nor the granules for oral suspension should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2).
Maltese: Minħabba li lformulazzjonijiet għandhom profili farmakokinetiċi differenti la l-pilloli li tomgħodhom u lanqas ilgranuli għal sospensjoni orali m'għandhom jiġu sostitwiti bil-pillola ta' 400 mg jew bil-pillola ta' 600 mg (ara sezzjoni 5.2).
English: ), median [range] CD4 percent, median [range] HIV-1 RNA >100,000 copies/mL CDC HIV category B or C Prior ART Use by Class NNRTI NRTI PI Response
Maltese: Kawkasjana Sewda Karatteristiċi tal-Linja Bażi Plasma HIV-1 RNA (log10 kopji/mL), medja [medda] Għadd taċ-ċelloli CD4 (ċelloli/mm3), medjan [medda] CD4 perċentwal, medjan [medda] HIV-1 RNA >100,000 kopja/mL CDC
English: ISENTRESS is also available for adults and paediatric patients (weighing at least 40 kg), as a 600 mg tablet to be administered as 1,200 mg once daily (two 600 mg tablets) for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Maltese: ISENTRESS huwa disponibbli wkoll għal pazjenti adulti u għal pazjenti pedjatriċi (li jiżnu tal-inqas 40 kg), bħala pillola ta' 600 mg li għandha tingħata bħala 1,200 mg darba kuljum (żewġ pilloli ta' 600 mg) għal pazjenti li qatt ma ħadu l-kura qabel jew pazjenti li huma mrażżnin viroloġikament fuq reġimen inizjali ta' ISENTRESS 400 mg darbtejn kuljum.
English: For weight between 11 and 20 kg either formulation can be used.
Maltese: †Għal piż bejn 11 u 20 kg tista' tintuża jew formolazzjoni jew oħra.
English: ISENTRESS film-coated tablets contain lactose.
Maltese: Il-proporzjonalità tad-doża ma ġietx stabbilita fil-pazjenti.
English: raltegravir AUC  10 % raltegravir C12hr  34 % raltegravir Cmax  11 %
Maltese: raltegravir C12hr ↓ 34% raltegravir Cmax ↓ 11%
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 f'Ġimgħa 24, ittrażżin tal-HIV RNA għal inqas minn 50 kopja/mL ġie miżmum f'84.4% tal-grupp li kien qiegħed jieħu raltegravir meta mqabbel ma' 90.6% tal-grupp li kien qiegħed jieħu lopinavir (+), (Min ma kompliex it-trattament = Falliment).
English: Their doctor may also want to prescribe the 400 mg tablet when they are able to swallow a tablet.
Maltese: It-tabib tagħhom jista' jkun irid jippreskrivi l-pillola ta' 400 mg meta jkunu kapaċi jibilgħu pillola.
English: raltegravir AUC  41% raltegravir C12hr  77% raltegravir Cmax  24%
Maltese: raltegravir C12hr ↑77% raltegravir Cmax ↑24%
English: raltegravir AUC  41 % raltegravir C12hr  77 % raltegravir Cmax  24 %
Maltese: raltegravir C12hr ↑ 77% raltegravir Cmax ↑ 24%
English: The most frequently reported serious adverse reactions were immune reconstitution syndrome and rash.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti kienu sindromu tarrikostuzzjoni immuni u raxx.
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 rċivew 400 mg raltegravir darbtejn kuljum, raltegravir instab faċilment fil-fluwidu tal-moħħ u tas-sinsla.