FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability of oral abacavir and lamivudine in adults is about 83% and 80-85% respectively.
Maltese: Il-bijodisponibbiltà assoluta ta' abacavir u lamivudine orali fl-adulti hija ta' madwar 83% u 80
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 mijokardijaċi u ma setgħetx tkun eskluża żieda żgħira fir-riskju.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u fin nutrizzjoni
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Maltese: (40 sa 90mg darba kuljum għal 14-il ġurnata /doża waħda ta' 600mg, imbagħad 600mg darbtejn kuljum għal 14-il ġurnata)
English: 30 tablets in opaque white (PVC/PVDCAluminium/Paper) child-resistant blister packs Multipacks containing 90 (3 packs of 30) tablets in opaque white (PVC/PVDC-Aluminium/Paper) child-resistant blister packs.
Maltese: Pakketti multipli li fihom 90 (3 pakketti ta' 30) pillola f'pakketti blister bojod opaki (PVC/PVDC
English: The adverse reactions considered at least possibly related to abacavir or lamivudine are listed by body system, organ class and absolute frequency.
Maltese: L-effetti avversi kkunsidrati li huma għallinqas possibilment relatati ma' abacavir jew lamivudine huma elenkati skond is-sistema tal-ġisem, klassi ta' l-organi u l-frekwenza assoluta.
English: The adverse reactions reported for Kivexa were consistent with the known safety profiles of abacavir and lamivudine when given as separate medicinal products.
Maltese: Ir-reazzjonijiet avversi rappurtati dwar Kivexa kienu jaqblu mal-profil ta' sigurta' ta' abacavir u lamivudine meta mogħtija bħala prodotti mediċinali separatament.
English: Hepatobiliary disorders
Maltese: Parametri metaboliċi
English: This was demonstrated in a single dose, 3-way crossover bioequivalence study of FDC (fasted) versus 2 x 300 mg abacavir tablets plus 2 x 150 mg lamivudine tablets (fasted) versus FDC administered with a high fat meal, in healthy volunteers (n = 30).
Maltese: Dan ħareġ minn studju b'doża waħda u bijoekwivalenza 3-way crossover ta' FDC(b'sawm) kontra żewġ pilloli ta' 300 mg abacavir flimkien ma' żewġ pilloli ta' 150 mg lamivudine (b'sawm) kontra
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Maltese: mediċini ma' lamivudine hi baxxa minħabba l-metaboliżmu limitat tal-fwied (5-10%)
English: Rash (usually maculopapular or urticarial)
Maltese: Raxx (ġeneralment makulopapulari jew urtikarjali)
English: Hepatic impairment
Maltese: Disturbi awtoimmuni
English: The inclusion of zidovudine in the regimen has been found to reduce the frequency of L74V and K65R selection in the presence of abacavir (with zidovudine: 0/40, without zidovudine: 15/192, 8%).
Maltese: zidovudine: 0/40, mingħajr zidovudine: 15/192, 8%).
English: Data from two studies, CAL30001 and ESS30008 demonstrated that Kivexa once daily has similar virological efficacy to abacavir 300 mg twice daily plus lamivudine 300 mg once daily or 150 mg twice daily in therapy-experienced patients.
Maltese: Dejta minn żewġ studji, CAL30001 u ESS30008 wriet li Kivexa mogħti darba kuljum għandu effikaċja viroloġika tixbah lil dik bi 300 mg abacavir mogħti darbtejn kuljum flimkien ma' 300 mg lamivudine mogħti darba kuljum jew 150 mg mogħti darbtejn kuljum f'individwi li kienu ħadu kura qabel.
English: Many of the adverse reactions listed in the table 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: 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 Kivexa 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, intgħażlu kif ġie ġie biex ikomplu b'din is-sistema jew jaqilbu għal Kivexa flimkien ma' PI jew NNRTI għal 48 ġimgħa.
English: - Triple nucleoside therapy: There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen.
Maltese: - Terapija tripla b'nukleosidi : Ġew rappurtati każi ta' rata għolja ta' indeboliment viroloġiku, u li nħolqot reżistenza fi stadju bikri meta abacavir u lamivudine ngħataw flimkien ma' tenofovir disoproxil fumarate b'kors ta' darba kuljum.
English: Passage of HIV-1 (HXB2) in the presence of increasing 3TC concentrations results in high-level (>100 to >500-fold) lamivudine-resistant viruses and the RT M184I or V mutation is rapidly selected.
Maltese: Il-passaġġ ta' HIV-1 (HXB2) fil-preżenza ta' konċentrazzjonijiet dejjem jiżdiedu ta' 3TC wassal għal virusis b'livell għoli ta' reżistenza għal lamivudine (>100 sa >500 darba) u l-mutazzjoni RT M184I jew V tintgħażel malajr.
English: Rarely, patients who have stopped abacavir for reasons other than symptoms of HSR have also experienced life-threatening reactions within hours of re- initiating abacavir therapy (see Section 4.8 Description of selected adverse reactions).
Maltese: Rarament, pazjenti li waqfu abacavir għal raġunijiet oħra minbarra sintomi ta' HSR esperjenzaw ukoll reazzjonijiet ta' periklu għall-ħajja fi ftit sigħat li reġgħu bdew it-terapija b'abacavir (ara Sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Efficacy Outcome at Week 48 in CNA30021 by baseline HIV-1 RNA and CD4 Categories (ITTe TLOVR ART naïve subjects).
Maltese: Riżultat tal-Effikaċja fil-Ġimgħa 48 f'CNA30021 skont il-Kategoriji ta' l-RNA ta' HIV-1 u CD4
English: Kivexa is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Kivexa mhuwiex rakkomandat li jingħata lil pazjenti b'indeboliment moderat jew serju tal-fwied (ara ssezzjoni 4.2 u 5.2).
English: Intravenous studies with abacavir and lamivudine showed that the mean apparent volume of distribution is 0.8 and 1.3 l/kg respectively.
Maltese: Distribuzzjoni Studji dwar l-għoti fil-vina ta' abacavir u lamivudine juru li l-medja tal-volum ta' distribuzzjoni apparenti kien ta' madwar 0.8 u 1.3 l/kg rispettivament.
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.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 (90%CI) ta' 1.89 drabi [1.32; 2.70] f'l-AUC ta' abacavir, u ta' 1.58 drabi [1.22; 2.04] fil-half-life ta' l-eliminazzjoni mill-ġisem.
English: Virologic Response Based on Plasma HIV-1 RNA < 50 copies/ml ITT-Exposed Population M=F switch included
Maltese: Rispons Viroloġiku Bbażat fuq RNA ta' HIV-1 ta'< 50 kopja/ml fil-Plażma
English: Virologic Response at Week 48 ITT-Exposed Population < 50 copies/ml TLOVR
Maltese: Rispons Viroloġiku fil-Ġimgħa 48 TLOVR ta' Popolazzjoni Esposta għal ITT < 50 kopja/ml ABC/3TC + EFV (N =192)
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, il-half-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: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti tattagħbija virali tal-HIV-1 meta l-għoti flimkien kroniku ma jkunx jista' jiġi evitat.
English: It is very important that you read and understand the information about this serious reaction.
Maltese: Huwa importanti ħafna li taqra u tifhem l-informazzjoni dwar din ir-reazzjoni serja.
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Maltese: L-esponimenti sistemiċi kienu ekwivalenti għal minn 7 sa 24 darba aktar mill-esponiment sistemiku li jkun mistenni fil-bnedmin.
English: The results of an in vivo rat micronucleus test with abacavir and lamivudine in combination were negative.
Maltese: Ir-riżultati ta' test mikronukleu in vivo fuq ġrieden b'abacavir u lamivudine flimkien kienu negattivi.
English: They were randomised to receive either abacavir (ABC) 600 mg once daily or 300 mg twice daily, in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily.
Maltese: darba kuljum jew 300 mg darbtejn kuljum, kombinati ma 300 mg lamivudine darba kuljum u 600 mg efavirenz darba kuljum.
English: The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, sodium starch glycollate u magnesium stearate fil qalba tal-pillola.
English: Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Maltese: TAT-TABIB...................................TEL...........................................
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the currently approved EU SPC:
Maltese: HSR u biex jespandu l-informazzjoni diġà inkluża fl-SPC tal-UE approvat bħalissa:
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Analogi ta' nuklejosidi u nuklejotidi ntwerew li jikkawżaw gradi differenti ta' ħsara fil-mitokondrija in vitro u in vivo.
English: ANTICONVULSANTS Phenobarbital/Abacavir
Maltese: Phenobarbital/Abacavir
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: L-ammonti 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' 600 mg abacavir darbtejn kuljum.
English: An interim analysis from ACTG 5202 revealed that abacavir/lamivudine was associated with a statistically significantly higher risk of virological failure as compared to emtricitabine/tenofovir (defined as viral load >1000 copies/mL at or after 16 weeks and before 24 weeks or HIV-RNA level
Maltese: Analiżi minn nofs l-istudju ACTG 5202 żvelat li abacavir/lamivudine kien assoċjat ma' riskju ogħla b'mod statistikament sinifikanti ta' falliment viroloġiku meta mqabbel ma' emtricitabine/tenofovir
English: Passage with a zidovudine resistant clinical isolate RTMC also selected for the 184V mutation.
Maltese: Meta ġie mgħoddi iżolat kliniku RTMC reżistenti għal zidovudine dan ukoll iffavorixxa l-għażla tal-mutazzjoni 184V.
English: Drug susceptibility scores were assigned for each patient's viral genotype utilising the ANRS 2009 HIV-1 genotypic drug resistance algorithm.
Maltese: Punteġġi ta' suxxettibiltà għall mediċina kienu assenjati għal kull ġenotip virali tal-pazjent bl-użu tal-algoriżmu ANRS 2009 ta' reżistenza ġenotipika ta' HIV-1 għall-mediċina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipacks of 90 (3 packs of 30 film-coated tablets) - without blue boxOUTER CARTON BLISTER PACK 30 TABLETS
Maltese: Pakketti mulitipli ta' 90 (3 pakketti ta' 30 pillola miksija b'rita) - mingħajr kaxxa blu KARTUNA TA' BARRA PAKKETT BIL-FOLJI 30 PILLOLA
English: Within this population, 104 HIV-1 infected paediatric subjects weighing at least 25 kg received abacavir and lamivudine as
Maltese: Fi ħdan din il-popolazzjoni, 104 individwi pedjatriċi infettati bl-HIV-1, li jiżnu għallinqas 25 kg irċevew abacavir u lamivudine bħala Kivexa darba kuljum.
English: Therapy
Maltese: Epatite
English: Response by Baseline HIV-1 RNA <100,000 c/mL
Maltese: HIV-1<100,000 k/ml
English: Among the 669 subjects randomized in this study (from 12 months to ≤17 years old), the abacavir/lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/mL at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200c/mL, <400c/mL, <1000c/mL), which all fell well within this non-inferiority margin.
Maltese: Fost is-669 individwu randomizzat f'dan l-istudju (minn 12-il xahar sa ≤17-il sena), il-grupp taddożaġġ ta' abacavir/lamivudine darba kuljum intwera li huwa mhux inferjuri għall-grupp ta' darbtejn kuljum skont il-marġini ta' nuqqas ta' inferjorità prespeċifikat ta' -12%, għall-punt ta' tmiem primarju ta' <80 c/mL f'Ġimgħa 48 kif ukoll f'Ġimgħa 96 (punt ta' tmiem sekondarju) u għall-punti tal-limitu l-oħrajn kollha ttestjati (<200c/mL, <400c/mL, <1000c/mL), li lkoll waqgħu sew fi ħdan dan ilmarġini ta' nuqqas ta' inferjorità.
English: Some clinical findings also support a possible interaction between lamivudine and cladribine
Maltese: Ċerti sejbiet kliniċi ukoll juru l-possibiltà ta' interazzjoni bejn lamivudine u cladribine
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: Before initiating abacavir therapy, clinicians should screen for HLA-B*5701 .
Maltese: • Qabel ma tinbeda t-terapija għandu dejjem jiġi dokumentat l-istatus HLA-B*5701.
English: Baseline RNA category <100,000 copies/mL
Maltese: Kategorija ta' RNA <100,000 kopja/mL fil-linja bażi
English: EPZ104057 (HEAT study) was a randomised, double-blind, placebo-matched, 96 week, multi-centre study with the primary objective of evaluating the relative efficacy of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir /emtricitabine (TDF/FTC, 300mg/200mg), each given once-daily in combination with lopinavir/ritonavir (LPV/r, 800mg/200mg) in HIV-infected, therapy-naive adults.
Maltese: (ABC/3TC, 600mg/300mg) u tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), li kull wieħed ingħata darba kuljum flimkien ma' lopinavir/ritonavir (LPV/r, 800mg/200mg) f'pazjenti adulti infettati bl-HIV, li qatt ma kienu fuq kura qabel.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Maltese: Rigressjoni fl-immudellar loġistiku tal-figuri predikattivi talġenotip (aġġustat għall-livell bażiku fil-plażma ta' HIV-1 RNA [VRNA], l-għadd ta' ċelloli CD4+, in numru u t-tul ta' terapiji antiretrovirali ta' qabel), wera li l-preżenza ta' 3 jew aktar mutazzjonijiet assoċċjati ma' resistenza b'NRTI, kellhom x'jaqsmu ma' respons mnaqqas fir-4
English: The concentration of drug necessary to effect viral replication by 50% (EC50) or 50% inhibitory concentration (IC50) varied according to virus and host cell type.
Maltese: Il-konċentrazzjoni ta' mediċina meħtieġa biex tikkawża effett ta' 50% fuq ir-replikazzjoni tal-virus (EC50) jew konċentrazzjoni inibitorja ta' 50% (IC50) varjat skont it-tip talvirus u taċ-ċellula li qed tilqa' fiha l-virus.
English: In vivo resistance (Therapy-naïve patients)
Maltese: Resistenza in vivo(Pazjenti li qatt ma ngħatalhom kura)
English: Other key symptoms include gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise.
Maltese: Sintomi ewlenin oħra jinkludu sintomi gastrointestinali, respiratorji jew kostituzzjonali bħal letarġija u telqa.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir and lamivudine.
Maltese: Studji kliniċi urew li m'hemmx interazzjonijiet kliniċi sinifikanti bejn abacavir u lamivudine.
English: Abacavir is metabolised by UDP-glucuronyltransferase (UGT) enzymes and alcohol dehydrogenase; co-administration of inducers or inhibitors of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Maltese: Abacavir jiġi mmetabolizzat permezz tal-enzimi UDP-glucuronyltransferase (UGT) u tal-alkoħol dehydrogenase; l-għoti tiegħu flimkien ma' indutturi jew impedituri tal-enzimi UGT jew flimkien ma'
English: Baseline CD4 category 101-200 57/ 85 (67%)
Maltese: Kategorija ta' CD4 101-200 fil linja bażi
English: • irritated or runny nose
Maltese: • imnieħer irritat jew inixxi
English: However, paediatric pharmacokinetic studies with tablet formulations have demonstrated that once daily dosing provides equivalent AUC24 to twice daily dosing of the same total daily dose.
Maltese: Madankollu, l-istudji farmakokinetiċi pedjatriċi bil-formolazzjonijiet tal-pillola urew li d-dożaġġ ta' darba kuljum jipprovdi AUC24 ekwivalenti għal dożaġġ darbtejn kuljum tal-istess doża totali ta' kuljum.
English: Abbreviations: ↑ = Increase; ↓ = decrease; ↔ = no significant change; AUC = area under the concentration versus time curve; Cmax = maximum observed concentration; CL/F = apparent oral clearance
Maltese: ↑ = Żieda; ↓=tnaqqis; ↔= l-ebda tibdil sinifikanti; AUC=erja taħt il-kurva tal konċentrazzjoni mal-ħin; Cmax= l-ogħla konċentrazzjoni osservata;
English: Cross-resistance between abacavir or lamivudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Maltese: Cross-resistance bejn abacavir jew lamivudine u antiretrovirali ta' klassijiet oħra e.g.
English: Body system
Maltese: Reżistenza
English: Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Twettqu biss studji ta' interazzjoni fl-adulti.
English: Common: fever, lethargy, fatigue.
Maltese: xylitol, mannitol, lactitol, maltitol).
English: Immune reactivation syndrome
Maltese: Sindromu ta' rijattivazzjoni immunitarja
English: WARNING!
Maltese: Terapewtiku
English: The median or mean EC50 values for lamivudine against laboratory strains of HIV-1 ranged from 0.007 to 2.3 µM.
Maltese: Il-valuri EC50 medjani jew medji għal lamivudine kontra razez HIV-1 tal laboratorju kienu fuq medda ta' bejn 0.007 u 2.3 µM.
English: Elderly:
Maltese: Methadone:
English: The combination of abacavir and lamivudine as a once daily regimen is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Maltese: Il-kombinazzjoni ta' abacavir u lamivudine mgħotija b'doża ta' darba kuljum ġiet studjata f' istudju kontrollat (CNA30021), double blind, f'ħafna ċentri, mifrux fuq 48 ġimgħa, ta'770 adulti nfettati bl
English: For the CNA109586 (ASSERT) and CNA30021 studies in treatment-naïve patients, genotype data was obtained for only a subset of patients at screening or at baseline, as well as for those patients who met virologic failure criteria.
Maltese: Għall-istudji CNA109586 (ASSERT) u CNA30021 f'pazjenti li qatt ma ħadu kura, dejta ġenotipika nkisbet biss f'sottosett ta' pazjenti waqt eżami jew fil-linja bażi, kif ukoll għal dawk il-pazjenti li ssodisfaw il-kriterji għal falliment viroloġiku.
English: Liver/pancreas
Maltese: Fwied/frixa
English: K65R
Maltese: Ma kienx hemm K65R u L74V
English: Abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
Maltese: Abacavir huwa primarjament metabolizzat mill-fwied u bejn wieħed u ieħor 2% tad-doża li tingħata titneħħa mill-ġisem permezz tal-kliewi, bħala sustanza mhux mibdula.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Maltese: Madankollu, l-attivita' anti-virali ewlenija tagħhom hi permezz ta' l-inkorporazzjoni tal-forma monofosfata fil-katina virali tad-DNA, li tirriżulta fid-distruzzjoni tal-katina.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti nfettati bl-HIV b'defiċjenza qawwija fl-immunita meta nbdiet tingħata t-terapija antiretrovirali kombinata (TARK), tista' tinħoloq reazzjoni infjammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali u tikkawża kondizzjonijiet kliniċi serji jew tiggrava s-sintomi.
English: MISCELLANEOUS Ethanol/Abacavir (0.7 g/kg single dose/600 mg single dose)
Maltese: (doża waħda ta' 0.7 g/kg/doża waħda ta' 600mg)
English: Routine risk minimisation activities
Maltese: Attivitajiet ta' rutina għall-minimizzazzjoni tarriskji
English: The safety database to support once daily dosing in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects (from 12 months to ≤17 years old).
Maltese: Il-bażi ta' dejta dwar is-sigurtà biex tappoġġa dożaġġ ta' darba kuljum f'pazjenti pedjatriċi toħroġ mill-Prova ARROW (COL105677) li fiha, 669 individwu pedjatriku infettati bl-HIV-1 (minn 12-il xahar sa ≤17-il sena) irċevew abacavir u lamivudine jew darba jew darbtejn kuljum (ara sezzjoni 5.1).
English: IMPORTANT - ALERT CARD Kivexa (abacavir / lamivudine) tablets Carry this card with you at all times
Maltese: IMPORTANTI - KARTUNA TA' TWISSIJA Pilloli Kivexa (abacavir /lamivudine)
English: The EC50 values of abacavir against HIV-1 Group M subtypes (A-G) ranged from 0.002 to 1.179 µM, against Group O from 0.022 to 1.21 µM, and against HIV-2 isolates, from 0.024 to 0.49 µM.
Maltese: 022 sa 1.21 µM, u kontra l-iżolati ta' HIV-2, minn 0.024 sa 0.49 µM.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti nfettati bl-HIV b'defiċjenza qawwija fl-immunita' meta tibda tingħatalhom terapija antiretrovirali kombinata, tista' titfaċċa reazzjoni infjammatorja għal infezzjonijiet opportunistiċi asintomatiċi jew residwali.
English: Within this population, 104 patients, weighing at least 25 kg, received 600 mg abacavir and 300 mg lamivudine as Kivexa once daily, with a median duration of exposure of 596 days.
Maltese: Fi ħdan din il-popolazzjoni, 104 pazjenti, li jiżnu għallinqas 25 kg, irċevew 600 mg abacavir u 300 mg lamivudine bħala Kivexa darba kuljum, b'tul ta' espożizzjoni medjan ta' 596 jum.
English: OPIOIDS
Maltese: ANTIKONVULŻIVI
English: Uncommon: Transient rises in liver enzymes (AST, ALT), Rare: Hepatitis
Maltese: Mhux komuni: Żjieda ta' enzimi tal-fwied(AST, ALT)
English: Common: nausea, vomiting, diarrhoea
Maltese: Komuni: nawżeja, remettar,
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 tas-sustanza li teħel mal-proteini tal-plażma.