FrancophonIA/ELRC3.0 huggingface dataset:
English: For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Maltese: Għal trapjanti tal-qalb, id-doża rakkomandata għall-adulti hija ta' 1.5 g darbtejn kuljum, li tinbeda fi żmien ħamest ijiem wara t-trapjant.
English: This means that Myclausen is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cellcept.
Maltese: Dan ifisser li Myclausen huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Cellcept.
English: Because Myclausen is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Peress li Myclausen huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu jitqiesu li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Myclausen?
Maltese: X'inhu Myclausen?
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth starting within 72 hours after the transplant.
Maltese: Għal trapjanti tal-kliewi, id-doża rakkomandata għall-adulti hija ta' 1 g darbtejn kuljum mill-ħalq li tibda fi żmien 72 siegħa wara t-trapjant.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Maltese: Jintuża maċ-ċiklosporina u l-kortikosterojdi (mediċini oħra biex jipprevjenu r-rifjut ta' organi).
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Maltese: Dan jagħmilhom inqas effikaċi f'li jagħrfu u jattakkaw l-organu trapjantat, u b'hekk jitbaxxa r-riskju li l-organu jiġi rifjutat.
English: By preventing the production of new DNA, Myclausen reduces the rate at which the lymphocytes multiply.
Maltese: Billi jipprevjeni l-produzzjoni ta' DNA ġdid, Myclausen inaqqas ir-rata li biha jimmultiplikaw il-limfoċiti.
English: How has Myclausen been studied?
Maltese: Kif ġie studjat Myclausen?
English: Myclausen is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Maltese: Myclausen mhuwiex rakkomandat għall-użu fi tfal wara trapjanti tal-qalb jew tal-fwied minħabba nuqqas ta' informazzjoni dwar l-effetti tiegħu f'dan il-grupp.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Maltese: Din l-enzima hija importanti fil-formazzjoni tad-DNA fiċċelloli, partikolarment fil-limfoċiti (tip ta' ċellola bajda fid-demm li hija involuta fir-rifjut tat-trapjanti tal-organi).
English: Why has Myclausen been approved?
Maltese: Għaliex ġie approvat Myclausen?
English: Therefore, the CHMP's view was that, as for Cellcept, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal filkaż ta' CellCept, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Abacavir is a NRTI.
Maltese: Abacavir huwa NRTI.
English: Therapy Abacavir + Combivir1
Maltese: Terapija Abacavir + Combivir1
English: Herts SG12 0DJ
Maltese: SG 12 0DJ
English: Ziagen 300 mg tablets.
Maltese: Ziagen 300 mg pilloli.
English: 240 ml oral solution
Maltese: 240 ml soluzzjoni orali
English: ARROW PK Substudy Part 1
Maltese: Sottostudju PK ta' ARROW Parti 1
English: WARNING!
Maltese: ATTENZJONI!
English: L74V Y115F M184V/I TAMs3
Maltese: L74V Y115F M184V/I MAT3
English: Date of first authorisation: 8 July 1999 Date of latest renewal: 21 March 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' Lulju 1999 Data tal-aħħar tiġdid: 21 ta' Marzu 2014
English: Percent with <400 copies/ml vRNA
Maltese: <400 copies/ml vRNA
English: Common: rash (without systemic symptoms)
Maltese: Komuni: raxx (mingħajr sintomi sistemiċi)
English: Do not take Ziagen:
Maltese: Tiħux Ziagen:
English: • methadone used as a heroin substitute.
Maltese: • methadone użat bħala sostitut tal-eroina.
English: Median Change vRNA (log10 c/ml)
Maltese: Bidla Medja vRNA (log10 c/ml)
English: Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Rari ħafna: erythema multiforme, sindromu ta' Stevens-Johnson u nekroliżi tossika epidermali
English: Virologic failure (HIV RNA >200 copies/ml)
Maltese: Falliment virologiku (HIV RNA>200 kopja/ml)
English: Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Maltese: Abacavir jifforma parti minn grupp ta' mediċini antiretrovirali msejħa nucleoside analogue reverse transcriptase inhibitors (NRTIs).
English: -4.8% (95% CI -11.5% to +1.9%), p=0.16
Maltese: -4.8% (95% CI -11.5% sa +1.9%), p=0.16
English: -2.3% (95% CI -9.3% to +4.7%), p=0.52
Maltese: -2.3% (95% CI -9.3% sa +4.7%), p=0.52
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Maltese: Glaxo Operations UK Ltd (fil-kummerċ bħala Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, Ir-Renju Unit.
English: The malformative risk is unlikely in humans based on those data.
Maltese: Ir-riskju malformattiv mhuwiex probabbli f'umani abbażi ta' dawk id-dejta.
English: The absolute bioavailability of oral abacavir in adults is about 83%.
Maltese: Il-biodisponibiltà totali ta` ta' abacavir orali fl-adulti huwa ta` madwar 83%.
English: -1.6% (95% CI -8.4% to +5.2%), p=0.65
Maltese: -1.6% (95% CI -8.4% sa +5.2%), p=0.65
English: Mitochondrial dysfunction following exposure in utero
Maltese: Disfunzjoni tal-mitokondrija wara l-esponiment in utero
English: Child-resistant foil blister packs (polyvinyl chloride/aluminium/paper) containing 60 tablets.
Maltese: Pakketti reżistenti għat-tfal fojl tal-folja (polyvinyl chloride / aluminju / karta) li fihom 60 pillola.
English: The tablet coating contains triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 and iron oxide yellow.
Maltese: Il-kisja tal-pillola fiha triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 u iron oxide isfar.
English: Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Maltese: Retinojdi: is-sustanzi retinojdi jiġu eliminati permezz ta' l-alcohol dehydrogenase.
English: (e.g. Kivexa, Trizivir, Triumeq)
Maltese: (eż. Kivexa, Ziagen, Triumeq)
English: Ziagen contains the active ingredient abacavir.
Maltese: Ziagen fih is-sustanza attiva abacavir.
English: Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Maltese: Zidovudine, didanosine, stavudine u tenofovir iżżommu l-attivita' antiretrovirali tagħhom kontra dawn it-tipi differenti ta' HIV-1.
English: Once Daily N (%)
Maltese: Darbtejn Kuljum N (%)
English: Phenotypic resistance and cross-resistance
Maltese: Reżistenza finotipika u cross-resistance:
English: It is a potent selective inhibitor of HIV-1 and HIV-2.
Maltese: L-HIV-1 u HIV-2.
English: Ziagen 20 mg/ml oral solution Abacavir
Maltese: Ziagen 20 mg/ml soluzzjoni orali Abacavir
English: • Therapy experienced adults
Maltese: • Adulti esperjenzati bit-terapija
English: The other ingredients are sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, artificial strawberry and banana flavour, purified water, sodium hydroxide and/or hydrochloric acid for pH adjustment.
Maltese: Is-sustanzi l-oħra huma sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, togħma artifiċjali tal-frawli u talbanana, ilma ppurifikat, sodium hydroxide u/jew hydrochloric acid għal aġġustament tal-pH.
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) were also similar in each group (ITT population).
Maltese: Il-proporzjonijiet b' HIV-1 RNA < 50 kopja/ml (50% kontra 47%) u < 400 kopja/ml (54% kontra 57%) kienu simili wkoll f'kull grupp (popolazzjoni ITT).
English: SN: NN
Maltese: NN
English: The calorific value of sorbitol is 2.6 kcal/g.
Maltese: Il-valur kalorifiku ta' sorbitol huwa 2.6 kcal/g.
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, lamivudine, stavudine, tenofovir or zidovudine, 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 nukleosidi (NRTIs - nucleoside reverse transcriptase inhibitors) didanosine, emtricitabine, lamivudine, stavudine, tenofovir jew zidovudine, mal-inibitur reverse transcriptase mhux nukleosidi (NNRTI - non-nucleoside reverse transcriptase inhibitor) nevirapine, jew malinibitur tal-protease (PI) amprenavir.
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: Irriżultati wrew li kien hemm żieda medja ta` 1.89-il darba [1.32; 2.70] f'l-AUC ta' abacavir, u ta' 1.58-il darba [1.22; 2.04] fil-half-life ta' l-eliminazzjoni mill-ġisem.
English: 3 to 12 years (N=36)
Maltese: 3 sa 12-il sena (N=36)
English: Hypersensitivity reactions (see also section 4.8):
Maltese: Reazzjonijiet ta' sensittività eċċessiva (ara wkoll sezzjoni 4.8):
English: Pharmacokinetic data were derived from 3 pharmacokinetic studies (PENTA 13, PENTA 15 and ARROW PK substudy) enrolling children under 12 years of age.
Maltese: Inkisbet dejta farmakokinetika minn 3 studji farmakokinetiċi (PENTA 13, PENTA 15 u ssottostudju PK ta' ARROW) li fihom ħadu sehem tfal taħt it-12-il sena.
English: Abacavir is metabolised intracellularly to the active moiety, carbovir 5'- triphosphate (TP).
Maltese: Abacavir jiġi mmetaboliżżat fiċ-ċelloli għal sustanza attiva, carbovir 5'-triphosphate (TP).
English: Once daily (600 mg) administration:
Maltese: Doża (600mg) darba kuljum:
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Analogi nucleoside u nucleotide intwerew in vitro u in vivo li jikkawżaw grad varjabbli ta' ħsara mitokondrijali.
English: Triple nucleoside therapy
Maltese: Terapija triplika bin-nukleosidi
English: Summary of Stead-State Plasma Abacavir AUC (0-24) (µg.h/ml) and Statistical Comparisons for Once and Twice-Daily Oral Administration Across Studies
Maltese: Sommarju ta' Abacavir fi Stat Stazzjonarju fil-Plasma AUC (0-24) (µg.h/ml) u Tqabbil Statistiku għall-Għoti Orali ta' Darba jew ta' Darbtejn Kuljum fl-Istudji
English: Contains amongst others: sorbitol (340 mg/ml, E420), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Maltese: Fih fost l-oħrajn: sorbitol (340 mg/ml, E420), methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216).
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: Fit48 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: ABC HSR and expand on the information already included in the currently approved EU SPC:
Maltese: ABC u biex jespandu fuq l-informazzjoni diġà inkluża fl-SPC tal-UE attwalment approvat:
English: The overall selection frequency for M184V or M184I was high (54%), and less common was the selection of L74V (5%), K65R (1%) and Y115F (1%).
Maltese: Il-frekwenza ta' selezzjoni totali għal M184V jew M184I kienet għolja (54%), u s-selezzjoni ta' L74V (5%), K65R (1%) u Y115F (1%) kienet anqas komuni.
English: The following convention has been used for their classification: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000) very rare (<1/10,000).
Maltese: Kienu klassifikati b'dawn il-kriterji:- komuni ħafna (>1/10), komuni (>1/100 sa <1/10), mhux komuni(>1/1,000 sa <1/100), rari (>1/10,000 sa
English: 2 years
Maltese: 2 snin
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: bħala l-preparazzjoni attiva waħdanija, ZIAGEN (Stati Uniti tal-Amerika Diċembru 1998, UE Lulju 1999).
English: Elevated liver function tests, hepatitis, hepatic failure
Maltese: Testijiet elevati tal-funzjoni tal-fwied, epatite, insuffiċjenza tal fwied
English: Additional risk minimisation activity
Maltese: Attività addizzjonali għall minimizzazzjoni tar-riskji
English: Pharmacotherapeutic group: nucleoside reverse transcriptase inhibitors, ATC Code: J05AF06
Maltese: Kategorija farmakoterapewtika - Inibituri tan-nuklejosajd reverse transcriptase, Kodiċi ATC:
English: These include:
Maltese: Azzjonijiet proposti:
English: For general Ziagen information enquiries, contact ……………….Tel …………… (local company name and telephone number will be inserted here).
Maltese: Għal informazzjoni ġenerali fuq Ziagen, kellem lil ……………….Tel ……………
English: Similar clinical success (point estimate for treatment difference -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Maltese: Suċċess kliniku simili (point estimate għal differenza fil-kura - 1.7, 95%CI8.
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Maltese: 3. Numru ta' suġġetti b'≥1 Mutazzjonijiet ta' l-Analogi ta' Thymidine (MAT).
English: Clinical description of abacavir HSR
Maltese: Deskrizzjoni klinika ta' HSR għal abacavir
English: Additionally, the efficacy and safety of abacavir given once daily has been demonstrated in a pivotal clinical study (CNA30021See section 5.1 Clinical experience).
Maltese: Barra dan, l-effikaċja u s-sigurtà ta' abacavir darba kuljum intweriet fi studju kliniku ta' importanza kbira (CNA30021 - Ara sezzjoni 5.1 Esperjenza klinika).
English: Phenotypic cross-resistance to other NRTIs with M184V or M184I mutation alone is limited.
Maltese: Cross-resistance finotipika għal NRTI oħra bil-mutazzjoni M184V jew M184IM waħedha hija limitata.
English: IMPORTANT - ALERT CARD ZIAGEN (abacavir) oral solution Carry this card with you at all times
Maltese: IMPORTANTI - ALERT CARD ZIAGEN (abacavir) soluzzjoni orali
English: Therefore, there is little potential for interactions with antiretroviral PIs and other medicinal products metabolised by major P450 enzymes.
Maltese: Għalhekk mhux probabli li jseħħu interazzjonijiet ma' PIs antiretrovirali u prodotti mediċinali oħra metabolizzati bl-enżimi ewlenien ta' P450.
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: Il-preżenza ta' M184V ma' K65R tagħmel cross-resistance ma' abacavir, tenofovir, didanosine u lamivudine.
English: Some medicines interact with Ziagen
Maltese: Mediċini oħra u Ziagen
English: Twice daily (300 mg) administration:
Maltese: Doża (300mg) darbtejn kuljum:
English: This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1).
Maltese: mg (15ml) darbtejn kuljum jew 600mg (30ml) darba kuljum (ara sezzjoni 4.4 u 5.1).
English: None M184V alone 75 -0.74 Any one NRTI
Maltese: M184V waħdu 75 -0.74
English: Abacavir has also been shown in vitro not to inhibit CYP 3A4, CYP2C9 or CYP2D6 enzymes at clinically relevant concentrations.
Maltese: Abacavir wera wkoll in vitro li ma jfixkilx l-enżimi CYP3A4, CYP2C9 jew CYP2D6 f`konċentrazzjonijiet klinikament rilevanti.
English: After a 600 mg abacavir tablet dose, the mean (CV) abacavir Cmax was approximately 4.26 µg/ml (28%) and the mean (CV) AUC∞ was 11.95 µg.h/ml (21%).
Maltese: Wara doża ta' pillola ta' 600mg ta' abacavir, ilmedja Cmax ta' abacavir (CV) kien bejn wieħed u ieħor 4.26μg/ml (28%) u l-medja ta' AUC kien 11.95μg.h/ml (21%).
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 mitokondrijali fi trabi negattivi għall-HIV esposti fl-utru u/jew wara t-twelid għal analogi nucleoside (ara sezzjoni 4.4).
English: Co. Durham DL12 8DT United Kingdom or
Maltese: Durham DL12 8DT Ir-Renju Unit jew
English: Manufacturer:
Maltese: Trasmissjoni:
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 kombinata għall-HIV'.
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 żdied abacavir biex iqawwi t-terapija, minn 166 suġġett, 123 (74%) kellhom M184V/I, 50(30%) kellhom T215Y/F, 45 (27%) kellhom M41L, 30
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street
Maltese: Glaxo Wellcome Operations Priory Street
English: Kivexa).
Maltese: iperlajpejżimja).
English: P450 does not play a major role in the metabolism of abacavir, and abacavir does not inhibit metabolism mediated by CYP 3A4.
Maltese: Il-P450 ma jieħux sehem importanti fil-metaboliżmu ta' abacavir, u abacavir ma' jfixkilx il-metaboliżmu li jseħħ permezz ta' CYP3A4.
English: The recommended dose of Ziagen is 600 mg daily (30 ml).
Maltese: Id-doża rrakkomandata ta` Ziagen hija 600mg kuljum (30ml).
English: Abacavir penetrates the cerebrospinal fluid (CSF) (see section 5.2), and has been shown to reduce HIV-1 RNA levels in the CSF.
Maltese: Abacavir jidħol fil-fluwidu ċerebrospinali (CSF) (ara sezzjoni 5.2), u deher li jnaqqas il-livelli ta` l-HIV-1 RNA fis-CSF.
English: Metabolism and nutrition disorders Common: anorexia Very rare: lactic acidosis
Maltese: Mard tal-metaboliżmu u nutrizzjoni Komuni: anoressja
English: The recommended dose is 8 mg/kg twice a day or 16 mg/kg once a day, up to a maximum total daily dose of 600 mg daily.
Maltese: Id-doża rrakkomandata hija 8 mg/kg darbtejn kuljum jew ta' 16 mg/kg darba kuljum, sa doża massima totali ta' 600 mg kuljum.
English: The EU SPC provides detailed information and advice relating to ABC HSR
Maltese: L-SPC tal-UE jipprovdi informazzjoni dettaljata u pariri relatati ma' HSR għal ABC
English: This is consistent with the known activity of other nucleoside analogues.
Maltese: Dan huwa konsistenti ma' l-attività magħrufa t`analogi tan-nuklejosajds oħra.
English: Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Maltese: HIV-1 RNA fil-plasma <80 c/ml Differenza fir-riskju (darba kuljum-darbtejn kuljum)
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 bil-plaċebo, randomised (1:1:1) double-blind, li sar f'1147 adult infettat bl-HIV-1 li qatt ma ħadu terapija antiretrovirali, fejn tqabblu 3 reġimenti:
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 markatur farmakoġenetiku identifikat konsistentement marbut maddijanjożi klinika ta' reazzjoni ta' HSR għal ABC.
English: Adults, adolescents and children (weighing at least 25 kg):
Maltese: Adulti, adolexxenti u tfal (li jiżnu tal-anqas 25 kg):
English: Sodium hydroxide and/or hydrochloric acid for pH adjustment.
Maltese: Sodium hydroxide u/jew hydrochloric acid biex taġġusta l-pH
English: Adults, adolescents and children weighing at least 25 kg The usual dose of Ziagen is 600 mg (30 ml) a day.
Maltese: Adulti, adoloxxenti u tfal li jiżnu tal-anqas 25 kg Id-doża tas-soltu ta' Ziagen hija 600 mg (30 ml) kuljum.
English: When full, the syringe contains 10 ml of solution.
Maltese: Meta mimlija s siringa fiha 10 ml ta' soluzzjoni.
English: Doctor: .......................……………… Tel: ...................……………………………………………..
Maltese: TAT-TABIB: .......................……Tel...................……………………………………………..
English: Adults, adolescents and children weighing at least 25 kg
Maltese: Adulti, adoloxxenti u tfal li jiżnu tal-anqas 25 kg
English: The bottle contains 240 ml (20 mg abacavir/ml) of solution.
Maltese: Il-flixkun fih 240 ml (20 mg abacavir/ml) ta'
English: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
Maltese: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, L-Olanda Il-Manufattur:
English: Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW (Observed Analysis)
Maltese: Rispons Viroloġiku Abbażi tal-HIV-1 RNA fil-Plasma ta' anqas minn 80 kopja/ml filĠimgħa 48 u fil-Ġimgħa 96 fir-randomizzazzjoni ta' abacavir + lamivudine Darba Kuljum kontra Darbtejn Kuljum ta' ARROW (Analiżi Osservata)
English: The data are displayed in the table below:
Maltese: Id-dejta qed tintwera fit tabella hawn taħt:
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: L74V u K65R fil-preżenza ta' abacavir (ma' zidovudine: 0/40, mingħajr zidovudine: 15/192,
English: The clinical relevance of this finding has not been determined.
Maltese: Ir-relevanza klinika ta`dan l-istħarriġ għadu ma ġiex determinat.
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, espożizzjoni 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' darbtejn kuljum.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir, zidovudine, and lamivudine.
Maltese: Studji kliniċi wrew li m`hemm l-ebda interazzjonijiet klinikament sinifikanti bejn abacavir, zidovudine, u lamivudine.
English: It is important to take Ziagen regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
Maltese: Huwa importanti li tieħu Ziagen b'mod regolari, għaliex jekk tieħdu f'intervalli irregolari, tista' tkun aktar probabbli li jkollok reazzjoni ta' sensittività eċċessiva.
English: In adults moderately exposed to antiretroviral therapy the addition of abacavir to combination antiretroviral therapy provided modest benefits in reducing viral load (median change 0.44 log10 copies/ml at 16 weeks).
Maltese: F'adulti li jkollhom esponiment moderat ta' terapija antiretrovirali l-użu ta' abacavir malkombinazzjoni tat-terapija antiretrovirali kienet ftit aktar effettiva biex tnaqqas il-viral load (bidla medjana 0.44 log10 kopji/ml f'16-il ġimgħa).
English: Ziagen and similar medicines may cause side effects in unborn babies.
Maltese: Ziagen u mediċini simili jistgħu jikkawżaw effetti sekondarji fi trabi mhux imwielda.
English: Myocardial Infarction
Maltese: Infart Mijokardiku
English: Children (weighing less than 25 kg):
Maltese: Tfal (li jiżnu anqas minn 25 kg):