FrancophonIA/ELRC3.0 huggingface dataset:
English: Opadry Green 03B11434 containing: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Maltese: Opadry Green 03B11434 li fih: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide isfar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/002 PCTFE/PVC-Al EU/1/00/156/004 PVC/PCTFE/PVC-Al/Paper
Maltese: EU/1/00/156/002 PCTFE/PVC-Al EU/1/00/156/004 PVC/PCTFE/PVC-Al/Karta
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Maltese: Glaxo Operations UK Ltd., (trading as Glaxo Wellcome Operations), Priory Street, Ware, Herts SG12 0DJ, Ir-Renju Unit jew
English: SIDE 1
Maltese: NAĦA 1
English: Median Change vRNA (log10 c/mL)
Maltese: Bidla Medjana vRNA (log10 c/mL)
English: Phenotypic resistance and cross-resistance
Maltese: Reżistenza fenotipika u cross-resistance:
English: BATCH NUMBER LOT
Maltese: NUMRU TAL-LOTT LOTT
English: Methadone and Trizivir
Maltese: Methadone u Trizivir
English: The absolute bioavailability of oral abacavir, lamivudine and zidovudine in adults is about 83 %, 80 - 85 % and 60 - 70 % respectively.
Maltese: Il-biodisponibbilta' assoluta ta' abacavir, lamivudine u zidovudine millħalq f'adulti hi madwar 83 %, 80-85 % u 60-70 % rispettivament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/003
Maltese: EU/1/00/156/003
English: Pharmacokinetic data has been obtained for abacavir, lamivudine and zidovudine separately.
Maltese: Id-data farmakodinamika nkisbet għal abacavir, lamivudine u zidovudine separatament.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 36 % serum albumin in vitro).
Maltese: Lamivudine juri farmakokinetiċi lineari fuq ilmedda ta' dożi terapewtiċi u tagħqid limitat ma' l-albumin maġġuri ta' proteini fil-plażma (<36 % albumin fis-serum in vitro).
English: 32 weeks 26 % 144 weeks
Maltese: 32 ġimgħa 26 % 144 ġimgħa
English: Table 1: Adverse reactions reported with the individual components of Trizivir
Maltese: Tabella1: Rapporti ta' reazzjonijiet avversi ma' komponenti individwali ta' Trizivir Abacavir
English: Rare: pancreatitis
Maltese: Rari: pankrejatite
English: The tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Maltese: Ir-rita tal-pillola fiha hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
English: Monitor for signs of zidovudine toxicity (see section 4.8).
Maltese: Immonitorja għal sinjali ta' tossiċità ta' zidovudine (ara sezzjoni 4.8).
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63 %, 80 % and 86 % for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Maltese: ġimgħa il-proporzjon ta' suġġetti b'HIV RNA < 50 kopja kull ml kienu 63 %, 80 % u 86 % għall fergħat ZDV/3TC/ABC, ZDV/3TC/EFV U ZDV/3TC/ABC/EFV rispettivament.
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, stavudine or tenofovir, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Maltese: L-attività antivirali ta' abacavir fil-kultura taċ-ċelloli ma ġietx antagonizzata meta kkombinat mal-inibituri reverse transcriptase nukleoside (NRTIs - nucleoside reverse transcriptase inhibitors) didanosine, emtricitabine, stavudine jew tenofovir, l-inibitur reverse transcriptase mhux nukleoside (NNRTInon-nucleoside reverse transcriptase inhibitor) nevirapine, jew l-inibitur tal-protease (PIprotease inhibitor) amprenavir.
English: Repeat-dose toxicity
Maltese: Tossiċita' minn dożi ripetuti
English: ( see reverse of card)
Maltese: (ara wara tal-karta)
English: Do not take Trizivir:
Maltese: X'fih Trizivir:
English: • methadone, used as a heroin substitute
Maltese: • methadone, li jintuża bħala sostitut ta' l-eroina.
English: Zidovudine AUC ↓48% (UGT induction)
Maltese: L-AUC ta' Zidovudine ↓48% (induzzjoni ta' UGT)
English: Zidovudine showed clastogenic effects in oral repeated dose micronucleus tests in mice and rats.
Maltese: Zidovudine were effetti klastoġeniċi f'testijiet ta' dożi ripetuti ta' mikronuklei fi ġrieden u firien.
English: The overall selection frequency for M184V or M184I was high (85 %), and selection of L74V, K65R and Y115F was not observed (see Table).
Maltese: Il-frekwenza ta' selezzjoni totali għal M184V jew M184I kienet għolja (85 %) u ma kienetx osservata selezzjoni ta' L74V, K65R u Y115F (ara t-Tabella).
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare (< 1/10,000).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (>1/10), komuni (>1/100 sa <1/10), mhux komuni(>1/1,000 sa <1/100), rari (>1/10,000 sa <1/1,000) rari ħafna (<1/10,000).
English: No antagonistic effects in vitro were seen with zidovudine and other antiretrovirals (tested agents: didanosine and interferon-alpha).
Maltese: L-effetti antagonistiċi in vitro dehru b'zidovudine u b'antiretrovirali oħrajn (aġenti ttestjati: didanosine u interferon-alpha).
English: 3'-amino-3'deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing.
Maltese: 3'amino-3'-deoxythymidine (AMT) ġie identifikat bħala metabolit ta' zidovudine wara dożi fil vina.
English: Rare: cardiomyopathy
Maltese: Rari: kardjomijopatija
English: K65R was absent and L74V and Y115F were uncommon (≤3 %).
Maltese: K65R u L74V u Y115F ma kienux komuni (≤3 %).
English: • inflammation of the pancreas (pancreatitis)
Maltese: • fjammazzjoni tal-frixa (pankrejatite)
English: Common: anaemia, neutropenia and leucopenia
Maltese: Komuni: anemija, newtropenija u lewkopenija
English: The results showed that there was a mean (90%CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Maltese: Ir-riżultati wrew li kien hemm żieda medja ta' 1.89 darbiet (1.32; 2.70) fl-AUC ta' abacavir, u ta' 1.58 darbiet (1.22; 2.04) flinżul għal nofs fil-livell ta' eliminazzjoni.
English: ANTIFUNGALS Fluconazole/Abacavir
Maltese: ANTIFUNGALI Fluconazole/Abacavir
English: URICOSURIC Probenecid/Abacavir
Maltese: URIKOSURICI Probenecid/Abacavir
English: Elevated liver function tests, hepatitis, hepatic failure
Maltese: Testijiet elevatital-funzjoni tal-fwied, epatite, insuffiċjenza talfwied
English: • Clinical description of abacavir HSR
Maltese: • Deskrizzjoni klinika ta' HSR għal abacavir
English: In vitro resistance
Maltese: Reżistenza in vitro:
English: In a meta-analysis of five clinical trials where abacavir was added to intensify therapy, of 166 subjects, 123 (74 %) had M184V/I, 50 (30 %) had T215Y/F, 45 (27%) had M41L, 30 (18 %) had K70R and 25 (15%) had D67N.
Maltese: F'meta-analiżi ta' ħames studji kliniċi fejn abacavir ġie miżjud biex iqawwi t-terapija, minn 166 suġġett, 123 (74 %) kellhom M184V/I, 50(30 %) kellhom T215Y/F, 45 (27 %) kellhom M41L, 30 (18 %) kellhom K70R u 25 (15 %) kellhom D67N.
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: HSR huma deni (~80%), raxx (~70%), sintomi gastrointestinali (>50%) bħal dardir, uġigħ addominali, rimettar, u dijarea, telqa ġeneralizzata, għeja, u uġigħ ta' ras (~50%) u sintomi oħra (~30%) bħalsintomi respiratorji, tal-mukuża, u muskolu-skeletali.
English: EU/1/00/156/004 - child-resistant foil PVC/PCTFE/PVC-Al/Paper Blister pack (60 Tablets)
Maltese: EU/1/00/156/004 - Pakkett b'folji blister tal-PVC/PCTFE/PVC-Al/Karta(60
English: Limited data from clinical trials do not indicate a significantly increased risk of adverse reactions to zidovudine with cotrimoxazole (see interaction information above relating to lamivudine and cotrimoxazole), aerosolised pentamidine, pyrimethamine and acyclovir at doses used in prophylaxis.
Maltese: Dejta limitata minn provi kliniċi ma turix riskju ogħla b'mod sinifikanti ta' reazzjonijiet avversi meta zidovudine jingħata ma' cotrimoxazole (ara l-informazzjoni dwar interazzjoni hawn fuq marbuta ma' lamivudine u co-trimoxazole), pentamidine aerosolizzat, pyrimethamine u acyclovir fid-dożi użati għall-profilassi.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Maltese: • mediċini (normalment liwkidi) li fihom sorbitol u alkoħol taz-zokkor ieħor (bħal xylitol, mannitol, lactitol jew maltitol), jekk jittieħdu regolarment.
English: Common: headache, insomnia Very rare: peripheral neuropathy (paraesthesiae)
Maltese: Rari ħafna: newropatija periferali(paresteżija)
English: (organic cation transporter inhibition)
Maltese: (impediment tat-trasportatur tal-katjoni organiċi)
English: • fits (convulsions)
Maltese: • aċċessjonijiet (konvulżjonijiet)
English: Clarithromycin/Lamivudine Interaction not studied.
Maltese: Clarithromycin/Lamivudine L-interazzjoni ma ġietx studjata.
English: Hypersensitivity Reactions (see also section 4.8 ):
Maltese: Reazzjonijiet ta' Sensittività Eċċessiva (ara wkoll is-sezzjoni 4.8):
English: Thymidine analogue mutations (TAMs) which are selected by zidovudine (ZDV) were also found (8%).
Maltese: Instabu wkoll mutazzjonijiet analogi ta' thymidine (TAMs) li huma magħżula minn zidovudine (8 %).
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44 %.
Maltese: Studji fuq abacavir juru proporzjon ta' CSF ma' AUC ta' plażma ta' bejn it-30 sa 44 %.
English: Rare: gynaecomastia
Maltese: Rari: ġinekomastja
English: Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔
Maltese: L-AUC ↔ Sulfamethoxazole:
English: Read the information ‘Other possible side effects of Trizivir' in Section 4 of this leaflet.
Maltese: Aqra l-informazzjoni 'Effetti sekondarji oħra possibli ta' Trizivir' f'Sezzjoni 4 ta' dan il fuljett.
English: “Pull here” (with Alert card attached)
Maltese: “ Iġbed hawn " (imwaħħal mal-Karta ta' Twissija)
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, nonnucleosides and other medicinal products metabolised by major P450 enzymes.
Maltese: Għalhekk, ftit li xejn hemm possibblità għal interazzjonijiet ma' mediċini antiretrovirali impedituri ta' protease, mhux nuklejosidi u prodotti mediċinali oħra mmetabolizzati mill-enzimi P450 prinċipali.
English: Dose reduction is required for patients with creatinine clearance ≤ 50 ml/min (see section 4.2).
Maltese: Tnaqqis tad-doża jkun meħtieġ f'pazjenti bi tneħħija ta' kreatinina ≤ 50 ml/min (ara t taqsima 4.2)
English: ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/3TC/EFV vs ZDV/3TC/ABC.
Maltese: ACTG5095 kien studju kliniku kkontrollat ta' plaċebo wieħed meħud bl-addoċċ, fejn la tabib u lanqas il-pazjent ma jkun jaf x'qiegħed jingħata, li sar f'1147 adult infettat bl-HIV-1 li qatt ma ħadu terapija antiretrovirali, fejn tqabblu 3 reġimenti: zidovudine (ZDV), lamivudine (3TC),
English: Phenotypic cross-resistance to other NRTIs with M184V or M184I mutation alone is limited.
Maltese: Cross-resistance fenotipika għal NRTI oħra bil-mutazzjoni M184V jew M184IM waħedha hija limitata.
English: Methadone/Zidovudine (30 to 90 mg once daily/200 mg every 4 hours)
Maltese: Methadone/Zidovudine (30 sa 90 mg darba kuljum/200 mg kull 4 sigħat)
English: • high doses of co-trimoxazole, an antibiotic
Maltese: • dożi għolja ta' co-trimoxazole, antibijotiku
English: In addition, the selection of L74V and K65R was reduced when co-administered with ZDV (K65R: without ZDV: 13/127, 10 %; with ZDV: 1/86, 1 %; L74V: without ZDV: 51/127, 40 %; with ZDV: 2/86, 2 %).
Maltese: 10 %: ma' ZDV: 1/86, 1 %; L74V: mingħajr ZDV: 51/127, 40 % ma' ZDV: 2/86, 2 %).
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase.
Maltese: Interazzjoni hija possibbli minħabba r-rotta komuni ta' eliminazzjoni permezz ta' alkoħol dehydrogenase.
English: Data show that abacavir, lamivudine and zidovudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Maltese: Data juru li abacavir, lamivudine u zidovudine jippenetraw is-sistema nervuża ċentrali (CNS) u jaslu sal-fluwidu ċerebrospinali.
English: Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Maltese: Iżolati ta' l-HIV reżistenti għal abacavirġew magħżula in vitro u ġew assoċjati ma bidliet genotipiċi speċifiċi f'RT codon region (codons M 184V, K65R, L74V, u Y115F).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: L- aktar reazzjonijiet avversi rappurtati huma mard ematoloġiku (anemija, newtropenja) u disturbi ta' metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: Common: myalgia Uncommon: myopathy
Maltese: Mhux komuni: mijopatija
English: Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Rari ħafna: eritema multiformi, sindromu ta' Stevens-Johnson u nekroliżi tossika epidermali urtikarja u għaraq
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Maltese: Methadone/Abacavir (40 sa 90mg darba kuljum għal 14-il ġurnata /doża waħda ta' 600mg, imbagħad 600mg darbtejn kuljum għal 14-il ġurnata)
English: Take the tablets at regular times, leaving approximately 12 hours between each tablet.
Maltese: Hu l-pilloli f'ħinijiet regolari, u ħalli bejn wieħed u ieħor 12-il siegħa bejn kull pillola.
English: ABC HSR Education Programme has been in place since the first approval of ABC as the single active preparation, ZIAGEN (USA December 1998, EU July 1999).
Maltese: HSR ilu fis-seħħ mill-ewwel approvazzjoni ta' ABC bħala preparazzjoni attiva waħdanija, ZIAGEN (l-Istati Unitital-Amerika Diċembru 1998, l-UE Lulju
English: They are listed by body system, organ class and absolute frequency.
Maltese: Huma elenkati skond is-sistema tal-ġisem, klassi ta' l-organi u l-frekwenza assoluta.
English: Abacavir, lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Maltese: Abacavir, lamivudine u zidovudine mhumiex immetabolizzati b'mod sinifikanti permezz talenzimi taċ-ċitokroma P450 (bħal ma huma CYP 3A4, CYP 2C9 jew CYP 2D6) u lanqas ma jimpedixxu jew jinduċu din is-sistema ta' enzimi.
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: Għalkemm effett antivirali simili ġie osservat bejn regoli dwar l-għoti ta' abacavir u indinavir f'termini ta' proporzjon ta' pazjenti b'piż virali li ma tinħassx (≤ 400 kopji/ml; analiżi ta' intenzjoni ta' kura (ITT), 47 % vs 49 %; analiżi ta' kura mogħtija (AT), 86 % vs 94 % għal tagħqid ta' abacavir u indinavir rispettivament),ir-riżultati kienu f-favur ittaħlita indinavir, partikolarment fis-sub-sett ta' pazjenti b'piż virali għolja (> 100,000 kopji/ml fillinja bażi;
English: Single dose lamivudine oral solution 300 mg
Maltese: Doża waħda ta' lamivudine soluzzjoni orali 300 mg Lamivudine:
English: • breakdown of muscle tissue
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue
English: Food decreased the rate of absorption of Trizivir (slight decrease Cmax (mean 18 - 32 %) and increase tmax (approximately 1 hour), but not the extent of absorption (AUC0-∞).
Maltese: L-ikel naqqas ir-rata ta' assorbiment ta' Trivizir (tnaqqis żgħir Cmax (medja 18-32) u żieda tmax (madwar siegħa), iżda mhux it-totalita' ta' l-assorbiment (AUC00).
English: Trizivir tablets are available in opaque white PCTFE/PVC-Al blister packs or child-resistant foil PVC/PCTFE/PVC-Al/Paper blister packs containing 60 tablets, or child resistant HDPE bottles containing 60 tablets.
Maltese: Il-pilloli ta' Trizivir huma disponibbli f'pakketti b'folji opaki bojod tal-PCTFE/PVC-Al jew f'pakketti b'folji tal-PVC/PCTFE/PVC-Al/Karta li ma jistgħux jinfetħu mit-tfal li jkun fihom 60 pillola, jew fi fliexken HDPE li ma jistgħux jinfetħu mit-tfal li jkun fihom 60 pillola.
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Maltese: Pazjenti ko-infettati bl-epatite C li qed jiġu kkurati b'alpha interferon u ribavirin huma ta' riskju speċjali.
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-farmakokinetiċi ta' abacavir ġew studjati f'pazjenti bi ħsara ħafifa tal-fwied (Child-Pugh punteġġ 5-6) li jieħdu 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 aktar mill-IC50 ta' abacavir ta' 0.08 µg/ml jew 0.26 µM meta abacavir jingħata f'dożi ta' 600 mg darbtejn kuljum.
English: The presence of M184V with Y115F gives rise to cross-resistance between abacavir and lamivudine.
Maltese: Y115F tagħmel cross-resistance bejn abacavir u lamivudine.
English: • pentamidine or atovaquone, to treat parasitic infections such as Pneumocystis jirovecii pneumonia (often referred to as PCP)
Maltese: • pentamidinejewatovaquone, biex jikkura infezzjonijiet b'parasiti bħal pulmonite kkawżata minn Pneumocystis jirovecii (ħafna drabi ssir referenza għaliha bħala PCP)
English: • lactic acidosis (excess lactic acid in the blood ; see the next section, ‘Other possible side effects of
Maltese: • aċidożi lattika (aċidu lattiku żejjed fid-demm, ara s-sezzjoni l-oħra, ‘Effetti sekondarji oħra possibli ta' Trizivir
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided.
Maltese: trimethoprim/ sulfamethoxazole għall-kura ta' pulmonite kkawżata minn Pneumocystis jirovecii (PCP) u toxoplasmosis ma ġewx studjati u għandhom jiġu evitati.
English: Viral resistance to abacavir develops relatively slowly in vitro, requiring multiple mutations for a clinically relevant increase in EC50 over wild-type virus.
Maltese: Reżistenza anti-virali għal abacavir tiżviluppa relattivament bil-mod in vitro, u tkun teħtieġ mutazzjonijiet multipli biex tilħaq żieda klinikament relevanti fl-EC50 fuq il-virus tip selvaġġ.
English: Immune Reactivation Syndrome
Maltese: Sindromu ta' Rijattivazzjoni Immunitarja
English: At a therapeutic dose (one Trizivir tablet twice daily) in patients, the mean (CV) steady-state Cmax of abacavir, lamivudine and zidovudine in plasma are 3.49 µg/ml (45 %), 1.33 µg/ml (33 %) and 1.56 µg/ml (83 %), respectively.
Maltese: B'doża terapewtika (pillola waħda ta' Trizivir darbtejn kuljum) fil-pazjenti, il-medja ta' Cmax fi stat stabbli ta' abacavir, lamivudine u zidovudine fil-plażma huma 3.49 μg/ml (45%), 1.33 μg/ml
English: Abacavir is associated with a risk for hypersensitivity reactions (HSR) (see section4.8) characterised by fever and/or rash with other symptoms indicating multi-organ involvement.
Maltese: Abacavir huwa assoċjat ma' riskju għal reazzjonijiet ta' sensittività eċċessiva (HSR) (ara sezzjoni 4.8) karatterizzati minn deni u/jew raxx ma' sintomi oħra li jindikaw l-involviment ta' ħafna organi.
English: • pyrimethamine, to treat malaria and other parasitic infections
Maltese: • pyrimethamine, biex jikkura l-malarja u infezzjonijiet oħra b'parasiti
English: Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 109/l), or abnormally low haemoglobin levels (< 7.5 g/dl or 4.65 mmol/l) (see section 4.4).
Maltese: Minħabba s-sustanza attiva zidovudine, Trizivir m'għandux jingħata lil pazjenti b'għadd baxx mhux normali ta' neutrophil (< 0.75 x 109/1), jew livelli baxxi mhux normali ta' emoglobina (< 7.5 g/dl jew 4.65 mmol/l) (ara t-taqsima 4.4)
English: Valproic acid/Zidovudine (250 mg or 500 mg thrice daily/100 mg thrice daily)
Maltese: Valproic acid/Zidovudine (250 mg jew 500 mg tliet darbiet kuljum/100 mg tliet darbiet kuljum)
English: No pharmacokinetic data are available in patients over 65 years of age.
Maltese: Ma jeżistux data farmakokinetiċi dwar pazjenti ta' 'l fuq minn 65 sena.
English: Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
Maltese: Data minn studji kliniċi urew numri limitati ta' infarti mijokardiċi u ma setatx tkun eskluża żieda żgħira fir-riskju.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (> 70 %) via the organic cationic transport system.
Maltese: 32 l/h/kg, bi tneħħija l-aktar mill-kliewi (> 70 %) permezz tas-sistema katjonika organika ta' trasport.
English: IMPORTANT - ALERT CARD TRIZIVIR (abacavir sulfate / lamivudine / zidovudine) Tablets Carry this card with you at all times
Maltese: IMPORTANTI - KARTA TA' TWISSIJA PILLOLI TRIZIVIR (abacavir sulfate/lamivudine/zidovudine)
English: • fluconazole or flucytosine, to treat fungal infections such as candida
Maltese: • fluconazolejew flucytosine, biex tikkura infezzjonijiet b'fungus bħal candida.
English: Blue-green capsule-shaped film-coated tablets engraved with “GX LL1” on one side.
Maltese: Pilloli blu-ħodor f'għamla ta' kapsula miksijin b'rita u “GX LL1 " mnaqqxa fuq naħa waħda.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite B jew C kronika fuq kura b'terapija antiretrovirali kombinata qegħdin f'riskju għoli ta' reazzjonijiet avversi serji u potenzjalment fatali fil-fwied.
English: Uncommon: dyspnoea Rare: cough
Maltese: Mhux komuni: qtigħ ta' nifs Rari: sogħla
English: Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqubiss fl-adulti.
English: • Trizivir 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 abacavir-containing regimen.
Maltese: • Trizivir 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: It is very important that you read and understand the information about this serious reaction.
Maltese: Huwa importanti ħafna li inti taqra u tifhem l-informazzjoni dwar din ir-reazzjoni serja.
English: Trizivir and similar medicines may cause side effects in unborn babies.
Maltese: Trizivir u mediċini simili jistgħu jikkawżaw effetti sekondarji fi trabi mhux imwielda.