FrancophonIA/ELRC3.0 huggingface dataset:
English: Ethanol: the metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%.
Maltese: Ethanol: il-metaboliżmu ta' abacavir jinibidel jekk jittieħed ma' l-ethanol u dan jirriżulta f'żieda fl-AUC ta' abacavir ta` madwar 41%.
English: This indicates a low likelihood for interactions with other medicinal products through plasma protein binding displacement.
Maltese: Dan jindika possibiltà baxxa ta' interazzjonijiet ma' prodotti mediċinali oħra permezz ta' spostament minn mal-proteini tal-plażma.
English: Children weighing ≥ 20 kg to < 25 kg: The recommended dose is 450 mg daily.
Maltese: Għal tfal li jiżnu > 20 kg sa < 25 kg: Id-doża rakkomandata hija ta' 450 mg kuljum.
English: For general Ziagen information enquiries, contact GlaxoSmithKline….Tel …………… (local company name and telephone number will be inserted here).
Maltese: Għal informazzjoni ġenerali fuq Ziagen, kellem lil GlaxoSmithKline….Tel ……………
English: Ziagen oral solution contains 340 mg/ml of sorbitol.
Maltese: It-tahlita ta`Ziagen li tittiehed mill-ħalq fiha 340 mg/ml ta` sorbitol.
English: Ziagen 300 mg film-coated tablets Abacavir
Maltese: Ziagen 300 mg pilloli miksija b`rita Abacavir
English: Other possible side effects of combination therapy for HIV
Maltese: Aqra t-tagħrif ‘Effetti sekondarji possibli oħra ta' terapija kombinata għall-HIV'
English: Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes
Maltese: Viroloġiċi Numru ta' Genotipi fuq Terapija
English: Cross-resistance between abacavir and antiretrovirals from other classes (e.g. PIs or NNRTIs) is unlikely.
Maltese: Cross-resistance bejn abacavir u antiretrovirali ta' tip ieħor (e.ż. PIs jew NNRTIs) mhix probabli.
English: The presence of M184V with Y115F gives rise to cross-resistance between abacavir and lamivudine.
Maltese: Il-preżenza ta' M184V ma' Y115F tagħmel cross resistance bejn abacavir u lamivudine.
English: In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to abacavir/lamivudine FDC plus a PI or NNRTI for 48 weeks.
Maltese: Fl-istudju ESS30008, 260 pazjent b'soppressjoni viroloġika fuq sistema ta' terapija first line bi 300 mg abacavir u 150 mg lamivudine, it-tnejn meħudin darbtejn kuljum flimkien ma' PI jew NNRTI, ġew randomised biex ikomplu b'din is-sistema jew jaqilbu għal abacavir/lamivudine FDC flimkien ma' PI jew NNRTI għal 48 ġimgħa.
English: Abacavir 16 mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Maltese: 16 mg/kg Darba Kuljum (95% Cl)
English: Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
Maltese: Studji in vitro dwar kemm jeħel mal-proteini tad-demm juru li abacavir jeħel ftit biss għal moderat (~49%) mal proteini tal-plażma umana f`konċentrazzjonijiet terapewtiċi.
English: • lactic acidosis (excess lactic acid in the blood)
Maltese: • aċidożi lattika (aċidu lattiku żejjed fid-demm).
English: Similarly, greater proportions of children treated with the abacavir containing combinations had HIV-1 RNA ≤50 copies/ml at 48 weeks (53%, 42% and 28% respectively, p=0.07).
Maltese: ta' ≤50 kopja/ml fit-48 ġimgħa (53%, 42% u 28% rispettivament, p=0.07).
English: Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl)
Maltese: Medja talProporzjon GLS tatTqabbil bejn Darba-Kontra Darbtejn Kuljum (90% Cl)
English: In a multicentre, double-blind, controlled study (CNA30024), 654 HIV-infected, antiretroviral therapy-naïve patients were randomised to receive either abacavir 300 mg twice daily or zidovudine 300 mg twice daily, both in combination with lamivudine 150 mg twice daily and efavirenz 600 mg once daily.
Maltese: Fi studju kliniku kkontrollat double-blind f'aktar minn ċentru wieħed, (CAN 30024), 654 pazjent infettati bl-HIV u li qatt ma ingħatalhom kura antiretrovirali, irċevew b'mod randomised jew abacavir 300mg jew zidovudine 300mg darbtejn kuljum, kemm flimkien ma' lamivudine 150mg darbtejn kuljum u efavirenz 600mg darba kuljum.
English: Results indicate that the FDC group was non-inferior to the abacavir twice daily group, based on similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38).
Maltese: Ir-riżultati indikaw li l-grupp li ħadu Kivexa ma kienux inferjuri għallgrupp li ħadu abacavir darbtejn kuljum , bażati fuq tnaqqis simili fl-HIV-1 RNA kif imkejjel b'żona medja taħt il-curve minus baseline (AAUCMB, -1.65 log10 kopji/ml kontra -1.83 log10kopji/ml rispettivament, 95% CI -0.13, 0.38).
English: At therapeutic dosages a dosage of 300 mg twice daily, the mean (CV) steady state Cmax and Cmin of abacavir are approximately 3.00 µg/ml (30%) and 0.01 µg/ml(99%), respectively.
Maltese: F`dożi terapewtiċi (doża ta' 300 mg darbtejn kuljum) f`pazjenti, il-medji (CV) fissi Cmax and Cmin ta' abacavir fil-plażma kienu bejn wieħed u ieħor 3.0 µg/ml (30%), u 0.01 µg/ml (99%), rispettivament.
English: • Ziagen should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
Maltese: • Ziagen qatt ma għandu jinbeda fuq pazjenti bi status pożittiv għal HLA-B*5701, u lanqas fuq pazjenti bi status negattiv għal HLA-B*5701 li kien kellhom HSR suspettat għal abacavir fuq skema preċedenti li kien fiha abacavir.
English: Film-coated tablet (tablets)
Maltese: KARTUNA TA' BARRA - PILLOLI
English: Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For the full list of excipients see section 6.1.
Maltese: Sorbitol (E420)340mg/ml Methyl parahydroxybenzoate (E218) 1.5mg/ml Propyl parahydroxybenzoate (E216) 0.18mg/ml
English: In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either the fixed-dose combination of abacavir/lamivudine (FDC) once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
Maltese: Fl-istudju CAL30001, 182 pazjent b'esperjenza tat-terapija u li kellhom indeboliment viroloġiku ġew randomised u ngħataw trattament b'doża fissa ta' abacavir/lamivudine (FDC) darba kuljum jew bi 300 mg abacavir darbtejn kuljum u 300 mg lamivudine darba kuljum, it-tnejn mgħotija flimkien ma' tenovir u PI jew NNRTI għal 48 ġimgħa.
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose ; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.
Maltese: Il-farmakokinetika ta' abacavir ġiet studjata f'pazjenti b'indeboliment epatiku ħafif (punteġġ Child-Pugh 5-6) li kienu qed jirċievu doża waħda ta` 600 mg; il-valur AUC medju (firxa) kien ta' 24.1 (10.4 sa 54.8) ug.
English: The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Maltese: Il-valuri osservati ta` l-ogħla konċentrazzjonijiet huma 9 darbiet akbar mill-IC50 ta' abacavir ta` 0.08 µg/ml jew 0.26 µM meta tingħata doża ta'abcavir ta' 600mg darbtejn kuljum.
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Maltese: Ma kienx hemm K65R u L74V u Y115F ma kienux komuni (≤3%).
English: Conclusions supported non-inferiority regardless of analysis method.
Maltese: inferjorità irrispettivament mill-metodu ta' analiżi.
English: IMPORTANT - ALERT CARD ZIAGEN (abacavir) tablets Carry this card with you at all times
Maltese: IMPORTANTI - ALERT CARD PILLOLI ZIAGEN (abacavir)
English: Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and
Maltese: Vajrus ta' Immunodefiċjenza Umana (HIV) fl-adulti, fl-adolexxenti u t-tfal (ara sezzjonijiet 4.4 u
English: Abacavir 8 mg/kg TwiceDaily Dosing Geometric Mean (95% Cl)
Maltese: 8 mg/kg Darbtejn Kuljum (95% Cl)
English: The other ingredients are microcrystalline cellulose, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica in the core of the tablet.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, sodium starch glycollate, magnesium stearate u colloidal anhydrous silica fil-qalba tal-pillola.
English: Film-coated Tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: In vitro resistance
Maltese: Reżistenza Reżistenza in vitro:
English: In PENTA 15 study, the geometric mean plasma abacavir AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 15.9 (8.86, 28.5) µg.h/ml in the once-daily dosing and 12.7 (6.52, 24.6) µg.h/ml in the twice-daily dosing.
Maltese: Fl-istudju PENTA 15, il-medja ġeometrika ta' abacavir fil plasma AUC(0-24) (95% CI) tal-erba' individwi taħt it-12-il xahar li qalbu minn skeda ta' darbtejn kuljum għal reġimen ta' darba kuljum (ara sezzjoni 5.1) hija ta' 15.
English: The recommended dose is:
Maltese: Perjodu ta' reviżjoni propost:
English: Each ml of oral solution contains 20 mg of abacavir (as sulfate).
Maltese: Kull ml ta' soluzzjoni orali fih 20 mg ta'abacavir (bħala sulfat).
English: Each ml of oral solution contains 20 mg of abacavir (as sulfate)
Maltese: Kull ml ta' soluzzjoni orali fih 20 mg ta' abacavir (bħala sulfate)
English: Maltodextrin
Maltese: TAGĦRIF
English: Intracellular pharmacokinetics
Maltese: .1 Propjetajiet farmakodinamiċi
English: What Ziagen is and what it is used for Ziagen is used to treat HIV (human immunodeficiency virus) infection.
Maltese: Ziagen jintuża għall-kura tal-infezzjoni tal-HIV (virus tal-immunodefiċjenza umana).
English: Abacavir hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: In a study of 20 HIV-infected patients receiving abacavir 300 mg twice daily, with only one 300 mg dose taken prior to the 24 hour sampling period, the geometric mean terminal carbovir-TP intracellular half-life at steady-state was 20.6 hours, compared to the geometric mean abacavir plasma half-life in this study of 2.6 hours.
Maltese: Fi studju ta' 20 pazjent infettati bl-HIV li kienu qed jieħdu 300 mg abacavir darbtejn kuljum, b'doża waħda ta' 300 mg meħuda qabel il-perijodu ta' 24 siegħa li fihom ittieħdu il-kampjuni, ilhalf-life terminali, medja, ġeometrika ta' carbovir-TP intra-ċellulari fi stat stabbli kienet ta' 20.6 sigħat, meta mqabbla mal-half-life medja ġeometrika ta' abacavir fil-plażma f'dan l-istudju ta' 2.6 sigħat.
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Maltese: Ir-rottot tal metaboliżmu prinċipali fil-bnedmin huwa bl-alcohol dehydrogenase u b`glucuronidation sabiex jiproduċi l-5'-carboxylic acid u 5'-glucuronide li jirrappreżentaw 66% tad-doża li tkun ittieħdet.
English: Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).
Maltese: Id-doża rrakkomandata hija ta' 8 mg/kg darbtejn kuljum jew ta' 16 mg/kg darba kuljum għal massimu ta' doża totali ta' kuljum ta' 600 mg (30 ml).
English: Manufacturer: Glaxo Operations UK Ltd, (trading as GlaxoWellcome Operations) Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom or ViiV Healthcare Trading Services UK Limited, 12 Riverwalk,
Maltese: Durham DL12 8DT ir-Renju Unit jew ViiV Healthcare UK Limited Trading Services, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irlanda
English: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1).
Maltese: Fil-Prova ARROW (COL105677) ħadu sehem 1206 pazjenti pedjatriċi infettati bl-HIV li l-età tagħhom kienet tvarja bejn it-3 xhur u 17-il sena, li 669 minnhom irċevew abacavir u lamivudine jew darba jew darbtejn kuljum (ara sezzjoni 5.1).
English: ( see reverse of card)
Maltese: (ara fuq wara tal-card)
English: Abacavir is primarily metabolised by the liver.
Maltese: Indeboliment epatiku Abacavir huwa primarjament metabolizzat mill-fwied.
English: In patients with high viral load (>100,000 copies/ml) the choice of a triple combination with abacavir, lamivudine and zidovudine needs special consideration (see section 5.1).
Maltese: F'pazjenti b` viral load għoli (>100,000 copies\ml) għandha tkun kunsidrata b'mod speċjali l għażla ta` kombinazzjoni tripla b`abacavir, lamivudine u zidovudine.(ara 5.1).
English: Children weighing 14 to < 20 kg: The recommended dose is 300 mg daily.
Maltese: Għal tfal li jiżnu minn 14 sa < 20 kg: Id-doża rakkomandata hija ta' 300 mg kuljum.
English: Ziagen is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2 ).
Maltese: Ziagen mhuwiex rakkomandat lill-pazjenti b`indeboliment moderat u sever talfwied (ara sezzjonijiet 4.2 u 5.2).
English: Elderly No pharmacokinetic data are currently available in patients over 65 years of age.
Maltese: Fil-preżent m'hemmx tagħrif farmakokinetiku f`pazjenti ta' età 'l fuq minn 65 sena.
English: If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Maltese: Għandu jkun hemm osservazzjoni mill-qrib jekk abacavir jiġi użat f'pazjenti b'indebboliment epatiku ħafif, inkluż osservazzjoni tal-livelli ta' abacavir fil-plażma jekk hu possibbli (ara sezzjonijiet 4.4 u 5.2).
English: Many of the adverse reactions listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Maltese: Ħafna mir-reazzjonijiet avversi elenkati hawn taħt iseħħu b'mod komuni (dardir, rimettar, dijarea, deni, letarġija, raxx) f'pazjenti b'sensittività eċċessiva għal abacavir.
English: take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa).
Maltese: L-RMP tal-UE tal-prodotti mediċinali li fihom abacavir (ABC) (Ziagen, Kivexa u Trizivir)
English: Interaction with abacavir is possible but has not been studied.
Maltese: Interazzjoni b`abacavir hija possibbli iżda għadha ma ġietx studjata.
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when abacavir was combined with tenofovir disoproxil fumarate and lamivudine as a once daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku u żvilupp ta'resistenza fi stadju talbidu meta abacavir ingħata f'kumbinazzjoni ma' tenofovir disoproxil fumarate u lamivudine darba kuljum.
English: No special requirements for disposal.
Maltese: Ilma purifikat.
English: The active substance in Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of the solution.
Maltese: Is-sustanza attiva f'Ziagen soluzzjoni orali hija 20 mg ta' abacavir (bħala sulfate) f'kull ml ta'
English: The degree of benefit as part of a new combination regimen will depend on the nature and duration of prior therapy which may have selected for HIV-1 variants with cross-resistance to abacavir.
Maltese: Kemm dan jista jservi bħala parti minn reġimen kombinat ġdid jiddependi minn-natura u t-tul tatterapija li tingħata qabel li jista jkun laqtet varjanti ta' l-HIV-1 b'cross-resistance għal abacavir.
English: The EU RMP of the abacavir (ABC) containing products (Ziagen, Kivexa and Trizivir) includes the following risk minimisation plan in relation to abacavir hypersensitivitiy reaction (HSR), which is an important identified risk:
Maltese: jinkludi l-pjan għall-minimizzazzjoni tar-riskji li ġej fir-rigward ta' reazzjoni ta' sensittività eċċessiva għal abacavir (HSR), li huwa riskju importanti identifikat:
English: As a general rule, when deciding to use antiretroviral agents for the treatment HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, both animal data as well as clinical experience in pregnant women should be taken into account.
Maltese: Bħala regola ġenerali, meta wieħed jiddeċiedi li juża aġenti antiretrovirali għall-kura tal infezzjoni tal-HIV f'nisa tqal u konsegwentament għat-tnaqqis tar-riskju ta' trasmissjoni vertikali tal-HIV fuq it-tarbija mhux imwielda, għandha tiġi kkunsidratakemm dejta mill-annimali kif ukoll esperjenza klinika f'nisa tqal.
English: No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6).
Maltese: (punteġġ Child-Pugh ta' 5-6).
English: Description of Selected Adverse Reactions
Maltese: Deskrizzjoni ta' Reazzjonijiet Avversi
English: Abacavir was not mutagenic in bacterial tests but showed activity in vitro in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the in vivo micronucleus test.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Abacavir ma kienx mutaġeniku f`testijiet batteriċi li saru iżda wera attività in vitro fil-lymphocyte chromosome aberration assay umana, fil-lymphoma assay tal-ġurdien, u l-in vivo micronucleus test.
English: If ABC hypersensitivity cannot be ruled out on clinical grounds, ABC should be permanently discontinued and should not be restarted, regardless of the results of HLA-B*5701 screening.
Maltese: ABC għandu jitwaqqaf b'mod permanenti, u ma għandux jerġa' jinbeda, irrispettivament mirriżultati tal-iskrinjar għal HLA-B*5701.
English: The pharmacokinetics of abacavir has not been studied in patients over 65 years of age.
Maltese: Il-farmakokinetika ta' abacavir ma ġietx studjata f`pazjenti ‘l fuq minn 65 sena.
English: The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function.
Maltese: Il-farmakokinetika ta' abacavir f`pazjenti fl-aħħar stadju ta' mard renali hija simili għal dik ta' pazjenti b`funzjoni normali tal-kliewi.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terapewtici
English: HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
Maltese: Skrinjar għal HLA-B*5701 għal riskju ta' sensittività eċċessiva għal ABC qatt ma għandu jieħu post viġilanza klinika xierqa u l-ġestjoni tal-pazjent f'individwi li qed jirċievu ABC.
English: Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Maltese: Dijanjożi ta' Reazzjoni ta' Sensittività Eċċessiva għal Abacavir Sintomi maġġuri assoċjati ma' HSR għal ABC huma deni (~80%), raxx (~70%), sintomi gastrointestinali (>50%) bħal dardir, uġigħ addominali, rimettar, u dijarea, telqa ġeneralizzata,
English: 2 to 12 years (N=14) PENTA 15 3 to 36 months (N=18)
Maltese: 3 sa 36 xahar (N=18)
English: Skin
Maltese: Studju
English: • fever (high temperature)
Maltese: • għeja, nuqqas ta' enerġija • deni (temperatura għolja)
English: In controlled clinical studies laboratory abnormalities related to Ziagen treatment were uncommon, with no differences in incidence observed between Ziagen treated patients and the control arms.
Maltese: Fi studji kliniċi kontrollati l-abnormalitajiet tal-laboratorju relatati mal-kura ta` Ziagen ma kienux komuni, u ma ġiet osservata l-ebda differenza fl-inċidenza ta' l-abnormalitajiet bejn pazjenti fuq Ziagen u dawk fil-grupp ta' kontroll.
English: Neurological/Psychiatry
Maltese: Newroloġiċi/Psikjatriċi
English: Do not take medicines containing sorbitol if you have hereditary fructose intolerance.
Maltese: Jekk għandek intolleranza ereditarja għal fructose tiħux mediċini li fihom sorbitol.
English: How to store Ziagen
Maltese: X'fih Ziagen
English: • if you have ever had liver disease, including hepatitis B or C
Maltese: • jekk qatt kellek mard tal-fwied, inkluż epatite B jew Ċ
English: In a separate study comparing the unblinded NRTI combinations (with or without blinded nelfinavir) in children, a greater proportion treated with abacavir and lamivudine (71%) or abacavir and zidovudine (60%) had HIV-1 RNA ≤400 copies/ml at 48 weeks, compared with those treated with lamivudine and zidovudine (47%)[ p=0.09, intention to treat analysis].
Maltese: Fi studju separat li qabbel il-kombinazzjonijiet mhux blindati ta' NRTI (bi jew mingħajr nelfinavir blindad) fit-tfal, kien hemm proporzjon akbar ta' dawk li rċevew kura b'abacavir u lamivudine (71%) jew b'abacavir u zidovudine (60%) li kellhom HIV-1 RNA ta' ≤400 kopja/ml fit-48 ġimgħa, meta mqabbla ma' dawk li rċevew kura b'lamivudine u zidovudine (47%) [p =
English: Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48.
Maltese: Tliet individwi kellhom tagħbija virali mhux rilevabbli u wieħed kellu HIV-RNA plażmatika ta' 900 kopja/ml fil-Ġimgħa 48.
English: ABC Hypersensitivity (including risk of reduced clinical vigilance for ABC HSR following HLA-B*5701 screening).
Maltese: Il-pazjenti li huma dijanjostikati b'reazzjoni ta' sensittività eċċessiva għandhom iwaqqfu abacavir immedjatament irrispettivament mill-istatus ta' HLA-B*5701.
English: Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and the liver, urinary bladder, lymph nodes and the subcutis of females.
Maltese: Tumuri malinni ħarġu fil-glandola prepuzzjali fl-annimali tas-sess maskili u fil-glandola klitorali fl-annimali tas-sess femminili taż-żewġ speċi.
English: • Children weighing at least 14 kg and less than 20 kg: The usual dose of Ziagen is 300 mg a day.
Maltese: • Tfal li jiżnu tal-anqas 14 kg u inqas minn sa 20 kg: Id-doża rakkomandata ta' Ziagen hija ta' 300 mg kuljum.
English: • fever (high temperature) and skin rash
Maltese: • deni (temperatura għolja) u raxx fil-ġilda.
English: Renal disease
Maltese: Mard renali
English: Ziagen film-coated tablets are engraved with ‘GX 623' on both sides.
Maltese: Ziagen pilloli miksija b'rita huma mmarkati b'‘GX 623' fuq iż-żewġ naħat.
English: Ziagen oral solution is clear to yellowish in colour which may turn into a brown colour over time with strawberry/banana flavouring.
Maltese: Ziagen soluzzjoni orali hija ċara sa safranija bħala kulur li tista' ssir kulur kannella matul iżżmien b'togħma ta' frawli/banana.
English: Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤400 copies/ml; intention to treat analysis (ITT), 47% versus 49%; as treated analysis (AT), 86% versus 94% for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (>100,000 copies/ml at baseline; ITT, 46% versus 55%; AT, 84% versus 93% for abacavir and indinavir respectively).
Maltese: kontra 49%; bħala analiżi tal-kura (AT), 86% kontra 94% għal kombinazzjonijiet ta'abacavir u ta' indinavir rispettivament), ir-riżultati wrew li l-kombinazzjonijiet ta' indinavir kienu aħjar, l-aktar f'dak il-grupp żgħir ta' pazjenti b`viral load għoli (>100,000 kopji/ml fil-linja bażi;
English: Each film-coated tablet contains 300 mg abacavir (as sulfate).
Maltese: Kull pillola miksija b`rita fiha 300 mg ta' abacavir (bħala sulfate).
English: The majority of these tumours occurred at the highest abacavir dose of 330 mg/kg/day in mice and 600 mg/kg/day in rats.
Maltese: abacavir ta` 330 mg/kg/kuljum fil-ġrieden u 600 mg/kg/kuljum fil-firien.