FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability of lamivudine (approximately 58 to 66%) was lower and more variable in paediatric patients under 12 years of age.
Maltese: Il-bijodisponibilità assoluta ta' lamivudine (madwar 58 sa 66%) kienet iktar baxxa u aktar varjabbli fil-pazjenti pedjatriċi li għandhom inqas minn 12-il sena.
English: Date of latest renewal: 17 November 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Diċembru 2004
English: The fixed-dose combination tablet of abacavir/lamivudine (FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately.
Maltese: Il-pillola kombinata b'doża fissa ta' abacavir/lamivudine (FDC) ġiet ppruvat li hi bijoekwivalenti għal lamivudine u abacavir meħudin separatament.
English: The mean EC50 for abacavir against laboratory strains of HIV-1IIIB and HIV-1HXB2 ranged from 1.4 to 5.8 µM.
Maltese: L-EC50 medja għal abacavir kontra razez ta' HIV-1IIIB u HIV-1HXB2 tal-laboratorju kienet fuq medda bejn 1.4 u 5.8 µM.
English: The clinical relevance of this is unknown.
Maltese: Ir-relevanza klinika ta'
English: Overall response (stratified by baseline HIV-1 RNA) Response by Baseline HIV-1 RNA <100,000 c/ml Response by Baseline HIV-1 RNA ≥100,000 c/ml
Maltese: Rispons skont Linja Bażi b'RNA ta' HIV-1<100,000 k/ml Rispons skont Linja Bażi b'RNA ta' HIV-1 ≥100,000 k/mL
English: ABC QD + 3TC QD + EFV QD (N=384) Number of Baseline Mutations1
Maltese: ABC QD + 3TC QD + EFV QD (N=384) Numru ta' Mutazzjonijiet fil-Linja Bażi1
English: Immune Reactivation Syndrome
Maltese: Sindromu ta' Riattivazzjoni Immuni
English: Elevated creatinine, renal failure
Maltese: Krejatinina għolja, insuffiċjenza renali
English: There are conflicting data in some comparative studies with Kivexa i.e. HEAT, ACTG5202 and ASSERT:
Maltese: HEAT, ACTG5202 u ASSERT:
English: Pancreatitis
Maltese: pankreatite
English: In vivo resistance
Maltese: Reżistenza in vivo
English: In a crossover study in 60 healthy volunteers, intracellular lamivudine-TP pharmacokinetic parameters were similar (AUC24,ss and Cmax24,ss) or lower (Ctrough - 24%) for the lamivudine 300 mg once daily regimen compared to the lamivudine 150 mg twice daily regimen.
Maltese: Fi studju crossover f'60 voluntier b'saħħithom, il-parametri farmakokinetiċi ta' lamivudine-TP fiċ-ċelluli kienu simili (AUC24,ss u Cmax,ss) jew aktar baxxi (Ctrough - 24%) għas-sistema ta' kura ta' lamivudine 300mg darba kuljum meta mqabbla mas-sistema ta' kura ta' lamivudine 150mg darbtejn kuljum.
English: The combination of lamivudine with cladribine is not-recommended (see section 4.5).
Maltese: It-taħlita ta' lamivudine ma' cladribine mhux rakkomandata (ara sezzjoni 4.5).
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Maltese: Aqra t-tagħrif ‘Effetti sekondarji possibli oħra ta' terapija kkombinata għall-HIV'
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.
Maltese: Għalhekk mhux probabbli li jseħħu interazzjonijiet ma' inibituri tal-protease antiretrovirali ma'nonnucleosides u prodotti mediċinali oħra metabolizzati bl-enzimi ewlenin ta' P450.
English: Mitochondrial dysfunction
Maltese: Disfunzjoni tal-mitokondrija
English: For lamivudine, the EC50 values against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Maltese: Għal lamivudine, il-valuri EC50 kontra s-sottotipi (A-G) ta' HIV-1 kienu fuq medda bejn 0.001 u 0.170 µM, kontra l-Grupp O bejn 0.030 u 0.160 µM u kontra l-iżolati ta' HIV-2 bejn 0.002 u 0.120 µM fiċ-ċelluli mononukleari tad-demm periferali.
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Maltese: id-data klinika disponibbli hija limitata ħafna u ma tippermettix li ssir konkluzzjoni ta' min joqgħod fuqha fil-qasam.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Maltese: Huwa importanti li taqra l-informazzjoni aktar l-isfel f'din is-sezzjoni taħt ‘Effetti sekondarji possibbli oħra ta' terapija kkombinata għall-HIV'.
English: Patients co-infected with chronic hepatitis B or C virus
Maltese: Pazjenti infettati wkoll bil-virus tal-epatite B jew Ċ kronika
English: In the fasted state there was no significant difference in the extent of absorption, as measured by the area under the plasma concentration-time curve (AUC) and maximal peak concentration (Cmax), of each component.
Maltese: assorbiment, imkejjel biż-żona ta' taħt l-concentration-time curve (AUC) tal-plażma u lkonċentrazzjoni massima(Cmax), ta' kull komponent.
English: Baseline HIV-1 samples from therapy-naive subjects with no amino acid substitutions associated with resistance have been evaluated using either the multi-cycle Virco Antivirogram™ assay (n=92 from COL40263) or the the single cycle Monogram Biosciences PhenoSense™ assay (n=138 from ESS30009).
Maltese: Kampjuni b'linja bażi ta' HIV-1 minn individwi li qatt ma ħadu kura qabel li ma kellhom l-ebda sostituzzjonijiet ta' aċidi amminiċi assoċjati ma' reżistenza ġew stmati bl-użu tal-assaġġ Virco Antivirogram™ multi ċikliku (n=92 minn COL40263) jew inkella l-assaġġ Monogram Biosciences PhenoSense™ b'ċiklu wieħed (n=138 minn ESS30009).
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Maltese: In-vitro lamivudine jwaqqaf il fosforrilizzazzjoni intraċellulari ta' cladribine li potenzjalment twassal għal riskju ta' nuqqas ta' effiċċjenza ta' cladribine filkażijiet ta' taħlit fl-isfond kliniku.
English: : + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Maltese: ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
English: CNA109586 (ASSERT study), a multi-centre, open label, randomised study of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), each given once daily with efavirenz (EFV, 600mg) in ART naïve, HLA-B*5701 negative, HIV-1 infected adults.The virologic results are summarised in the table below:
Maltese: abacavir/lamivudine (ABC/3TC, 600mg/300mg) u tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), li kull wieħed ingħata darba kuljum ma' efavirenz (EFV, 600mg) f'pazjenti adulti infettati bl-HIV-1, li qatt ma kienu kkurati b'ART qabel u kienu negattivi għal HLA-B*5701.
English: Abacavir and lamivudine 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 u lamivudine m'humiex metabolizzati b'mod sinifikanti b'enzimi cytochrome P450 (bħal CYP 3A4, CYP 2C9 jew CYP 2D6) u lanqas ma jimpedixxu jew jinduċu din is-sistema ta' enzimi.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li ngħatat prova li suppressjoni virali effikaċi b'terapija antiretrovirali tnaqqas b'mod sostanzjali r-riskju ta' trażmissjoni sesswali, ma jistax jiġi eskluż riskju residwu.
English: Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine
Maltese: Kivexa pilloli ta' 600 mg/300 mg. abacavir/lamivudine
English: The IC50 for wild-type HXB2 is 0.24 to 0.6 µM, while the IC50 for M184V containing HXB2 is >100 to 500 µM.
Maltese: L-IC50 għat-tip HXB2 li jinstab fin-natura hija bejn 0.24 u 0.6 µM, filwaqt li l-IC50 għal M184V li fiha HXB2 hija >100 sa 500 µM.
English: Following multiple-dose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/ml (26%) and the mean (CV) AUC24 is 8.87 µg.h/ml (21%).
Maltese: Wara t-teħid mill-ħalq ta' doża multipla ta' 300 mg lamivudine darba kuljum għal sebat ijiem, il medja (CV) fi stat stabbli ta' Cmax hi 2.04 µg/ml (26%) u l-medja (CV) ta' l-AUC24 hi 8.87 µg.h/ml
English: Clinical experience with the combination of abacavir and lamivudine as a once daily regimen is mainly based on four studies in treatment-naïve subjects, CNA30021, EPZ104057 (HEAT study), ACTG5202, and CNA109586 (ASSERT study) and two studies in treatment-experienced subjects, CAL30001 and ESS30008.
Maltese: Esperjenza klinika bit-taħlita ta' abacavir u lamivudine bħala skeda ta' għoti ta' doża darba kuljum hija l-biċċa l-kbira bbażata fuq erba' studji f'individwi li qatt ma kienu ħadu kura qabel, CNA30021, EPZ104057 (studju HEAT), ACTG5202, u CNA109586 (studju ASSERT) u żewġ studji f'individwi li kienu ħadu kura qabel, CAL30001 u ESS30008.
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 ikkawżata minn Pneumocystis jirovecii (PCP) u toxoplasmosis ma ġewx studjati u għandhom jiġu evitati.
English: The combination of abacavir and lamivudine has demonstrated antiviral activity in cell culture against non-subtype B isolates and HIV-2 isolates with equivalent antiviral activity as for subtype B isolates.
Maltese: It-taħlita ta' abacavir flimkien ma' lamivudine uriet attività antivirali f'kolturi ta' ċelluli kontra iżolati mhux tas-sottotip B u iżolati ta' HIV-2 b'attività antivirali bħal dik tal-iżolati tas-sottotip B.
English: The mean EC50 against laboratory strains of HIV-2 (LAV2 and EHO) ranged from 1.57 to 7.5 µM for abacavir and from 0.16 to 0.51 µM for lamivudine.
Maltese: L-EC50 medja kontra razez ta' HIV-2 (LAV2 uEHO) tal-laboratorju kienet fuq medda bejn 1.57 u 7.5 µM għal abacavir u bejn 0.16 u 0.51 µM għal lamivudine.
English: Rare: Rises in serum amylase.
Maltese: Żjieda ta' amylase fisserum.
English: EXP
Maltese: ABC
English: Who gets these reactions?
Maltese: Kien hemm każi ta'
English: These resulted in median EC50 values of 0.912 µM (range: 0.493 to 5.017 µM) and 1.26 µM (range 0.72 to 1.91 µM) respectively for abacavir, and median EC50 values of 0.429 µM (range: 0.200 to 2.007 µM) and 2.38 µM (1.37 to 3.68 µM) respectively for lamivudine.
Maltese: 72 sa 1.91 µM) rispettivament għal abacavir, u valuri medjani ta' EC50 ta' 0.429 µM (medda: 0.200 sa 2.007 µM) u 2.38 µM (1.37 sa 3.68 µM) rispettivament għal lamivudine.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma concentrations.
Maltese: Lamivudine ma were ebda attivita' ġenotossika fl-istudji in vivo fejn ingħataw dożi li wasslu għal konċentrazzjonijiet fil-plażma sa 40-50 darba ogħla minn konċentrazzjonijet fil-plażma kliniċi.
English: How to take Kivexa
Maltese: Tieħux Kivexa.
English: ABC BID +3TC QD (n=88)
Maltese: BID +3TC QD (n=88)
English: L74V Y115F M184V/I TAMs3
Maltese: trippli 74V/115Y/184V.
English: • difficulty in sleeping (insomnia)
Maltese: • diffikultà biex torqod (insonnja)
English: PHARMACEUTICAL PARTICULARS
Maltese: PRODOTTI MEDIĊINALI
English: The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Maltese: Il-varjanti ta' M184V u M184I issibhom f'pazjenti nfettati bl-HIV-1 li jingħataw trattament antiretrovirali li fih lamivudine.
English: Number of Baseline Mutations1
Maltese: Numru ta' Mutazzjonijiet fil-Linja Bażi1
English: Virologic Response
Maltese: Rispons Viroloġiku
English: Write your doctor's details below:
Maltese: Interazzjonijiet ma' Mediċini:
English: Baseline RNA category >=100,000 copies/mL
Maltese: Kategorija ta' RNA >=100,000 kopja/mL fil-linja bażi
English: Abacavir-resistant isolates of HIV-1 have been selected in-vitro in wild-type strain HIV-1 (HXB2) and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115).
Maltese: Iżolati ta' HIV-1 reżistenti għal abacavir intgħażlu in vitro fir-razza ta' HIV-1 (HXB2) li tinstab finnatura u huma assoċjati ma' tibdiliet ġenotipiċi speċifiċi fil-parti tal-kodon RT (kodons M184V, K65R, L74V u Y115).
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (Punteġġ ta' Child-Pugh ta' 5-6) ikun meħtieġ monitoraġġ sew, inkluż il-monitoraġġ tal-livelli ta' abacavir fil-plażma jekk possibbli (ara s-sezzjonijiet 4.4 u 5.2).
English: The clinical relevance of this finding has not been determined.
Maltese: Ir-relevanza klinika ta'dan l-istħarriġ ma ġietx determinata.
English: Kivexa contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen).
Maltese: Kivexa fih abacavir (li huwa wkoll sustanza attiva f'mediċini bħal Trizivir, Triumeq u Ziagen).
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Maltese: Numru ta' individwi b'≥1 Mutazzjonijiet ta' l-Analogu ta' Thymidine (TAMs).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/298/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/298/002
English: Excipient(s) with known effect: sunset yellow FCF (E110) 1.7 mg per tablet For the full list of excipients see section 6.1.
Maltese: Eċċipjent(i) b'effett magħruf: sunset yellow FCF (E110) 1.7mg f'kull pillola.
English: • breakdown of muscle tissue.
Maltese: • ħsara fit-tessut tal-muskoli.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Maltese: Data in vitro għandha t-tendenza li turi li l-kontinwazzjoni ta' lamivudine f'sistema ta' kura antiretrovirali minkejja l-iżvilupp ta' M184V tista' tipprovdi attivita' antiretrovirali residwa (li tista' tiġri minħabba li l-virus ma jibqax jiffunzjona sewwa).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltriċi u tattessuti konnettivi
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Maltese: Dejta disponibbli attwalment hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Very rarely cases of erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Maltese: Ġew irrapportata każijiet rari ħafna ta' eritema multiforme, is-sindromu ta' Stevens-Johnson jew nekroliżi epidermali tossika fejn ma setgħetx tiġi eskluża sensittività eċċessiva għal abacavir.
English: Response by Baseline HIV-1 RNA ≥100,000 c/mL
Maltese: HIV-1≥100,000 k/ml
English: At week 48, a lower rate of virologic response was observed for ABC/3TC compared to TDF/FTC (point estimate for the treatment difference: 11.6%, 95% CI: 2.2, 21.1).
Maltese: Fil-ġimgħa 48, kienet ossevata rata ta' rispons viroloġiku aktar baxxa għal ABC/3TC meta mqabbla ma' TDF/FTC (stima ta' punt għad-differenza fil-kura: 11.6%, 95% CI: 2.2, 21.1).
English: Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties.
Maltese: Kemm Abacavir, kif ukoll lamavudine jiġu metabolizzati sekwenzjalment b'kinases ta' ġoċ-ċelloli, għall-5'-triphosphate rispettivi (TP) li huma l parti attiva.
English: Kivexa is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg.
Maltese: Kivexa jintuża għall-kura tal-infezzjoni tal-HIV (virus tal-immunodefiċjenza umana) fl-adulti, adoloxxenti u fi tfal li jiżnu għallinqas 25 kg.
English: There have been reports of mitochondrial dysfunction in HIVnegative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Maltese: Kien hemm rapporti ta' disfunzjoni tal-mitokondrija fi trabi negattivi għall-HIV li fil-ġuf u/jew wara t-twelid kienu esposti għal analogi ta' nuklejosidi(ara sezzjoni 4.4).
English: Additionally, the efficacy and safety of this combination given once daily has been demonstrated in a pivotal clinical study (CNA30021- See Clinical experience).
Maltese: Barra dan, l-effikaċja u s-sigurtà ta' din ilkombinazzjoni ta' darba kuljum intweriet fi studju kliniku ta' importanza kbira (CNA30021 - Ara Esperjenza klinika).
English: ACTG 5202 study was a, multi-centre, comparative, randomised study of double-blind abacavir/lamivudine or emtricitabine/tenofovir in combination with open-label efavirenz or atazanavir/ritonavir in treatment-naïve HIV-1 infected patients.
Maltese: L-istudju ACTG 5202 kien studju multiċentriku, kunparattiv, randomised ta' abacavir/lamivudine jew emtricitabine/tenofovir li kienu double-blind flimkien ma' efavirenz jew atazanavir/ritonavir li kienu open-label f'pazjenti infettati bl-HIV 1 li qatt ma kienu fuq kura qabel.
English: Reproductive toxicology
Maltese: Tossiċita fuq is-sistema riproduttiva
English: In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24,ss + 32%, Cmax24,ss + 99% and Ctrough + 18%) compared to the 300 mg twice daily regimen.
Maltese: Fi studju crossover f'27 pazjent infettat bl-HIV, l-espożizzjonijiet għal carbovir-TP ġewwa ċ-ċellola kienu aktar għoljin għas-sistema ta' kura b'abacavir 600mg darba kuljum (AUC24,ss + 32%, Cmax 24,ss + 99% u C trough + 18%) meta mqabbla mas-sistema ta' kura ta' 300mg darbtejn kuljum.
English: HLA-B*5701 is the only identified pharmacogenetic marker that is consistently associated with clinical diagnosis of an ABC HSR reaction.
Maltese: HLA-B*5701 huwa l-uniku indikatur farmakoġenetiku identifikat li huwa assoċjat b'mod konsistenti ma' dijanjosi klinika ta' reazzjoni ABC
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: • lactic acidosis (excess lactic acid in the blood)
Maltese: • aċidożi lattika (aċidu lattika żejjed fid-demm).
English: Continued passage in increasing concentrations of drug resulted in selection for double RT mutants 65R/184V and 74V/184V or triple RT mutant 74V/115Y/184V.
Maltese: Meta komplew jiġu mgħoddija minn konċentrazzjonijiet dejjem jiżdiedu ta' mediċina dan wassal għal għażla favur mutanti RT doppji 65R/184V u 74V/184V jew mutanti RT
English: It is important to take Kivexa regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
Maltese: Huwa importanti li tieħu Kivexa b'mod regolari, għaliex jekk tieħdu f'intervalli irregolari, tista' tkun aktar probabbli li jkollok reazzjoni ta' sensittività eċċessiva.
English: ABC BID +3TC+EFV (n=386)
Maltese: BID +3TC+EFV (n=386)
English: • hypersensitivity reaction
Maltese: • reazzjoni ta' sensittività eċċessiva
English: Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1).
Maltese: Kivexa hija indikata għal terapija antiretrovirali kombinata għall-kura ta' l-infezzjoni bil- virus ta' Immunodefiċjenza Umana (HIV) f'adulti, adolexxenti u tfal li jiżnu għallinqas 25 kg (ara sezzjonijiet
English: The GSS was obtained from the Monogram reports with susceptible virus ascribed the values ‘1-4' based upon the numbers of drugs in the regimen and with virus with reduced susceptibility ascribed the value ‘0'.
Maltese: Il-GSS inkiseb minn rapporti ta' Monogrammi bil-virusis suxxettibbli attribwiti l-valuri ‘1-4' fuq bażi tan-numru ta' mediċini fl-iskeda u bil-virus b'suxxettibiltà mnaqqsa attribwit il-valur ‘0'.
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: L-RMP tal-UE ta' prodotti li fihom abacavir (ABC) (Ziagen, Kivexa u Trizivir) jinkludi dan li pjan għall-minimizzazzjoni tar-riskji rigward reazzjoni ta' sensittività eċċesiva (HSR
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia
Maltese: Mhux komuni: Newtropenja u anemija(it-tnejn kultant qawwijin ħafna), tromboċitopenja Rari ħafn: Aplażja ta' ċelluli ħomor biss
English: • Kivexa 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: • Kivexa 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: Intracellular pharmacokinetics
Maltese: Ittestjar Farmakoġenetiku
English: Baseline CD4 category 201-350 101/143 (71%)
Maltese: Kategorija ta' CD4 201-350 fil linja bażi
English: Results at 48 weeks indicated that the Kivexa group was associated with a similar virologic outcome (non-inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV-1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Maltese: Ir-riżultati fit-48 ġimgħa indikaw li l-grupp ta' Kivexa kien assoċjat ma' riżultat viroloġiku simili mhux inferjuri, paragunat mall-grupp ta' abacavir u lamivudine, bażati fuq proporzjonijiet ta' individwi b' HIV-1 RNA < 50 kopji/ml (90% u 85% rispettivament, 95% CI -2.7,
English: For general Kivexa information enquiries, contact [local company name and telephone number inserted here]
Maltese: Għal informazzjoni ġenerali fuq Kivexa, kellem lil [isem il-kumpanija lokali u n-numru tat-telefown imdaħħla hawnhekk]
English: Miscellaneous
Maltese: Mixxellanji
English: Symptoms may include:
Maltese: Azzjonijiet proposti:
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 jeħlu mal-proteini tal-plażma juru li abacavir jeħel ftit jew moderatament (~49%) ma' proteini tal-plażma umani f'konċentrazzjonijiet terapewtiċi.
English: • Emtricitabine, to treat HIV infection
Maltese: • Emtricitabine, biex tikkura infezzjoni bl-HIV
English: The presence of M184V with K65R does give rise to crossresistance between abacavir, tenofovir, didanosine and lamivudine, and M184V with L74V gives rise to cross-resistance between abacavir, didanosine and lamivudine.
Maltese: K65R tikkawża cross-resistance bejn abacavir, tenofovir, didanosine u lamivudine.
English: Combivir is a fixed dose combination of lamivudine and zidovudine 2.
Maltese: 1. Combivir fih doża fissa ta' taħlita ta' lamivudine u zidovudine 2.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi, u medjastinali
English: ABC BID+ 3TC QD + EFV QD (N=386)
Maltese: BID+ 3TC QD + EFV QD (N=386)
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Maltese: Deni, letarġija, telqa, edema, limfadenopatija, pressjoni baxxa,
English: Antiviral therapy According to Genotypic/Phenotypic Resistance
Maltese: Terapija Antivirali Skont ir-Reżistenza Ġenotipka/Fenotipika
English: They are orange and capsuleshaped and are provided in blister packs containing 30 tablets and multipack blister packs containing 90(3 x 30) tablets.
Maltese: Għandhom kulur oranġjo u forma ta' kapsula u huma disponibbli f'pakketti tal-fojl li fihom 30 pillola u f'pakkett multiplu b'pakketti tal-fojl li fihom 90(3 x 30) pillola.