FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' każi ta' funzjonament mitokondrjali ħażin fi trabi negattivi għall-HIV, li kienu esposti, in utero u/jew wara t-twelid, għal analogi tan-nukleosidi: dawn kienu predominantament jikkonċernaw kura b'korsijiet li fihom zidovudine.
English: Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children.
Maltese: Epivir jintuża biex jikkura l-infezzjoni bl-HIV (virus tal-immunodefiċjenza umana) fl-adulti u fit-tfal.
English: The likelihood of metabolic interactions of lamivudine with other medicinal products is low due to the small extent of hepatic metabolism (5-10%) and low plasma protein binding.
Maltese: Il-probabbilta' ta' interazzjonijiet metaboliċi ta' lamivudine ma' prodotti mediċinali oħra hija żgħira minħabba li l-ammont ta' metaboliżmu fil-fwied huwa żgħir (5-10%) t-tagħqid mal-proteini talplażma huwa baxx.
English: Each ml of oral solution contains 10 mg lamivudine
Maltese: Kull ml ta' soluzzjoni orali fiha 10 mg lamivudine
English: Excipients: Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Maltese: Pazjenti dijabetiċi għandhom ikunu mwissija li kull doża (150mg =15ml) fiha 3g ta' sucrose.
English: Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Analogi nukleosidi u nukleotidi jikkawżaw ħsara mitokondrjali varjabbli kemm in vitro u kemm in vivo.
English: BLISTER CARTON X 30 FILM-COATED TABLETS (300 mg )
Maltese: KARTUNA TAL-FLIXKUN X 30 PILLOLA MIKSIJA B'RITA (300mg)
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Maltese: Fi studju farmakokinetiku (PENTA 15), erba' individwi kkontrollati viroloġikament li kellhom inqas minn 12-il xahar qelbu minn reġimen ta' soluzzjoni orali darbtejn kuljum għal darba kuljum ta' abacavir flimkien ma' lamivudine.
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Maltese: Il-metaboliżmu ta' lamivudine ma jinvolvix CYP3A, u għalhekk mhux probabbli li jkun hemm interazzjonijiet ma' prodotti mediċinali li jiġu metabolizzati b'din is-sistema (e.ż PI).
English: This can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor.
Maltese: Din tista' tingħata bħala 75 mg (nofs pillola ta' 150 mg) li tittieħed filgħodu u 150 mg (pillola sħiħa ta' 150 mg) li tittieħed filgħaxija, jew 225 mg (pillola u nofs ta' 150 mg) li tittieħed darba kuljum.
English: 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: Il-grupp ta' dożaġġ ta' darba kuljum ta' abacavir + lamivudine ntwera li mhuwiex inferjuri għal grupp ta' dożaġġ ta' darbtejn kuljum skont il-marġni ta' nuqqas ta' inferjorità speċifikat minn qabel ta'12 %, għall-punt ta' tmiem primarju ta' <80 c/ml f'Ġimgħa 48 kif ukoll f'Ġimgħa 96 (punt ta' tmiem sekondarju) u l-livelli limitu l-oħrajn kollha li ġew ittestjati (<200 c/ml, <400 c/ml, <1000 c/ml), li kollha waqgħu sew f'dan il-marġni ta' nuqqas ta' inferjorità.
English: This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Maltese: Dan ma jkunx jeħtieġ tibdil tad-doża sakemm il-pazjent ma jkunx ibati wkoll minn indeboliment tal-kliewi (ara taqsimiet 4.5 u 4.2).
English: BLISTER CARTON X 60 FILM-COATED TABLETS (150 mg)
Maltese: KARTUNA BI FLIXKUN X 60 PILLOLA MIKSIJA B'RITA (150 mg)
English: Not applicable.
Maltese: Ilma purifikat
English: Drug Interactions: Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Maltese: Epivir m'għandux jittieħed ma' prodotti mediċinali oħra li fihom lamivudine jew prodotti mediċinali li fihom emtricitabine (ara sezzjoni 4.5).
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided (see section 4.4).
Maltese: Ikkunsidra monitoraġġ aktar frekwenti tat-tagħbija virali tal-HIV-1 meta l-għoti flimkien kroniku ma jkunx jista' jiġi evitat (ara sezzjoni 4.4).
English: Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V mutations.
Maltese: It-terapija anti-retrovali b'aktar minn mediċina waħda li tinkludi lamivudine irriżulta li kienet effettiva f'pazjenti naïve anti-retroviralment kif ukoll f'pazjenti bil-virus bil-mutazzjonijiet M184V.
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Maltese: Ċertament, id-data klinika disponibbli hija limitata ħafna u ma tħallix li ssir konklużzjoni fil-qasam li ta' min joqgħod fuqha.
English: Mitochondrial dysfunction following exposure in utero: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Analogi tan-nukleosidi u tan-nekleotidi jistgħu jaffettwaw il-funzjoni mitokondrjali sa grad varjabbli, li ġiet innutata l-iktar bi stavudine, didanosine u zidovudine.
English: Sucrose 20 % w/v (3 g/15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate
Maltese: Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid anhydrous Propylene glycol Sodium citrate Togħma artifiċjali ta' frawli Togħm artifiċjali ta' banana
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Maltese: Eżempji relevanti jinkludu retinite b'cytomegalovirus, infezzjonijiet lokali jew mifruxa b'mycobacterium, u pnewmonja b'Pneumocystis jirovecii (ħafna drabi ssir referenza għaliha bħala PCP).
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance.
Maltese: Il-probabbilta' ta' interazzjonijiet metaboliċi hi baxxa minħabba l-metaboliżmu limitat u t-tagħqid malproteina fil-plażma u t-tneħħija kważi totali mill-kliewi.
English: Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48.
Maltese: Tlett individwi kellhom tagħbija virali li ma setgħetx titkejjel u wieħed kellu HIV-RNA plażmatika ta' 900 kopja/ml wara Ġimgħa 48.
English: mannitol, lactitol or maltitol), if taken regularly
Maltese: mannitol, lactitol jew maltitol), jekk jittieħdu regolarment mediċini oħra li fihom lamivudine,
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia
Maltese: Mhux komuni: Newtropenja u anemija (it-tnejn li huma kultant serji), tromboċitopenja Rari ħafna: Aplasija pura ta ċ-ċelluli l-ħomor
English: Paediatric pharmacokinetic studies with both oral solution and tablet formulations have demonstrated that once daily dosing provides equivalent AUC0-24 to twice daily dosing of the same total daily dose.
Maltese: L-istudji dwar il-farmakokinetika pedjatrika kemm bis-soluzzjoni orali kif ukoll bil-formolazzjonijiet tal-pilloli wrew li dożaġġ ta' darba kuljum jipprovdi AUC0-24 ekwivalenti għal darbtejn kuljum id-dożaġġ tal-istess doża totali ta' kuljum.
English: Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided.
Maltese: L-għoti ta' lamivudine flimkien ma' dożi qawwija ta co-trimoxazole għall-kura tal-pulmonite Pneumocystis jirovecii (PCP) u toxoplażmożi għandu jiġi evitat.
English: 25 mg (2.5 ml) once daily
Maltese: 25mg (2.5ml) darba kuljum
English: Adults, adolescents and children (weighing at least 25 kg):
Maltese: Adulti, adolexxenti u tfal (li jiżnu tal-inqas 25 kg):
English: If Epivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see Zeffix SPC).
Maltese: Jekk Epivir jitwaqqaf f'pazjenti ko-infettati bil-virus ta' l-epatite B, huwa rrakkomandat monitoraġġ perjodiku ta' testijiet għall-funzjoni tal-fwied u sustanzi li jimmarkaw ir-replikazzjoni ta' l-HBV, għaliex it-twaqqif ta'lamivudine jista' jikkawża lill-epatite tmur għal agħar b'mod akut (ara taqsima Zeffix SPC).
English: In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
Maltese: F'kull ċirkostanza, huwa dejjem preferibbli li jinbdew NRTI suxxettibli milli terapija regolari b'lamivudine.
English: The active ingredient in Epivir is lamivudine.
Maltese: Is-sustanza attiva f'Epivir hija lamivudine.
English: This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull mL, jiġifieri essenzjalment ‘ħielsa mis-sodju'.
English: These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Maltese: Dawn ir-riżultati inkisbu f'popolazzjoni mingħajr esperjenza ta' kura antiretrovirali, li tikkonsisti primarjament minn pazjenti infettati bl-HIV mingħajr sintomi (CDC stadju A).
English: It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Maltese: Huwa jagħmel parti minn grupp ta' mediċini msejħa inibituri ta' reverse transcriptase analogi għal nucleoside (NRTI).
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 events.
Maltese: Pazjenti bl-epatite kronika B jew C li jkun fuq terapija antiretrovirali kkombinata ikunu f'riskju ogħla ta' avvenimenti avversi serji u li jistgħu ikunu fatali.
English: Once daily dosing (300 mg once a day): a clinical study has demonstrated the non inferiority between Epivir once a day and Epivir twice a day containing regimens.
Maltese: Doża ta' darba kuljum (300mg darba kuljum): studju kliniku wera n-nuqqas ta' inferjorita' bejn sistemi ta' kura b'Epivir darba kuljum u Epivir darbtejn kuljum.
English: Pancreatitis: Cases of pancreatitis have occurred rarely.
Maltese: Każi rari ta' pankreatite.
English: The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi meqjusa li huma għallinqas possibbilment relatati mal-kura huma elenkati hawn taħt skont is-sistema fil-bniedem, il-klassi tal-organi u l-frekwenza assoluta.
English: Conclusions supported non-inferiority regardless of analysis method.
Maltese: Il-konklużjonijiet appoġġjaw in-nuqqas ta' inferjorità irrispettivament mill-metodu ta' analiżi.
English: Methyl parahydroxybenzoate Propyl parahydroxybenzoate Each 15 ml dose contains 300 mg propylene glycol.
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali Epivir 150 mg pilloli miksijin b'rita Fliexken tal-HDPE:
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Maltese: Bħala regola ġenerali, meta tabib jiddeċiedi li jagħti sustanzi antiretrovirali għall-kura ta' infezzjoni tal-HIV f'nisa tqal u konsegwentament għat-tnaqqis tar-riskju ta' trasmissjoni vertikali tal-HIV littarbija li tkun għadha kif twieldet, id-dejta mill-annimali kif ukoll l-esperjenza klinika f'nisa tqal għandhom jiġu kkunsidrati.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Pazjenti li kienu diġa' jbatu b'disfunzjoni tal-fwied, inkluża l-epatite kronika attiva, ikollhom Żjieda fil-frekwenza ta' anormalitajiet fil-funzjoni tal-fwied waqt it-terapija kkombinata antiretrovirali, u għandhom ikunu monitorjati skont il-prattika standard.
English: This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4).
Maltese: Din tista' tingħata jew 150 mg darbtejn kuljum jew 300 mg darba kuljum (ara taqsima 4.4).
English: Glomerular filtration estimates suggests that to achieve similar adult and paediatric exposure, an appropriate dose for children aged six weeks and older could be 8 mg/kg/day.
Maltese: Stimi ta' filtrazzjoni glomerulari jindikaw li biex tinkiseb espożizzjoni simili fl-adulti u fit-tfal, id-doża xierqa għal tfal ta' sitt ġimgħat u aktar tista' tkun ta' 8 mg/kg/kuljum.
English: Rare side effects
Maltese: Effetti sekondarji komuni
English: White, diamond shaped scored tablets engraved with “GX CJ7” on both faces.
Maltese: Pillola bajda, forma ta' djamant b'marka biex taqsamha minn-nofs u b' "GX CJ7 " inċiż fuq iż-żewġ naħat.
English: Tel: +385 1 6051 999
Maltese: GlaxoSmithKline d.o.o. Tel: +385 1 6051 999
English: Signs of osteonecrosis include:
Maltese: Sinjali ta' ostjonekrożi jinkludu:
English: • being sick (vomiting)
Maltese: • taqla' (rimettar)
English: Uncommon: Transient elevations in liver enzymes (AST, ALT) Rare: Hepatitis
Maltese: Mhux komuni: Għoli mhux permanenti fil-livelli ta' l-enzimi tal-fwied (AST, ALT)
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Maltese: Lamivudine ma kienx ġenotossiku in vivo f'dożi li pproduċew konċentrazzjonijiet fil-plażma ta' madwar 40-50 darba aktar mill-livelli kliniċi fil-plażma imbassra.
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Maltese: Lamivudine ma nstabx li hu mutaġeniku f'testijiet batterjali imma, bħal ħafna analogi nuklejosidi, wera attivita' f'analiżi ċitoġenetika in vitro u fl-analiżi ta' linfoma fil-ġrieden.
English: Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl)
Maltese: Proporzjon Medju ta' GLS ta' Paragun bejn Dożaġġ ta' Darba Kuljum u Darbtejn Kuljum (90% Cl)
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Maltese: Prodotti mediċinali oħra (e.ż ranitidine, cimetidine) jitneħħew biss parzjalment b'dan il-mekkaniżmu u ntwera li ma hemmx interazzjonijiet ma' lamivudine.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV, b'defiċjenza immunitarja severa fiż-żmien li tkun inbdiet it-terapija antiretrovirali kkombinata (CART), jista' jkun hemm reazzjoni infjammatorja għall-mikrobi opportunistiċi moħbija jew residwi.
English: 0.9 mg/kg once daily
Maltese: 0.9 mg/kg darba kuljum
English: 100 mg (10 ml) once daily
Maltese: 100mg (10ml) darba kuljum
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia)
Maltese: • diffikultà biex torqod (insomnja)
English: Paediatric Population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving the oral solution of Epivir as compared to those receiving the tablet formulation.
Maltese: Fi studju mwettaq f'pazjenti pedjatriċi (ara sezzjoni 5.1 studju ARROW), rati aktar baxxi ta' soppressjoni viroloġika u reżistenza virali aktar frekwenti ġew irrapportati fi tfal li rċevew is-soluzzjoni orali ta' Epivir meta mqabbla ma' dawk li rċevew il-formulazzjoni tal-pillola.
English: Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47 %).
Maltese: Meta lamivudine jingħata mal-ikel dan jirriżulta f'dewmien ta' Tmax. u f'Cmax aktar baxx ( imnaqqas b'47%).
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogueDNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Maltese: L-istudju wera li feti esposti in utero għat-taħlita sostnew livelli ogħla ta' inkorporazzjoni fid-DNA ta' analogi tan-nukleosidi f'ħafna mill-organi tal-fetu, u kien hemm evidenza ta' aktar tqassir ta' telomere minn dawk esposti għal zidovudine waħdu.
English: They are grey, diamond shaped film-coated tablets, marked with the code ‘GXEJ7' on one side.
Maltese: Huma pilloli griżi, forma ta' djamant, miksijin b'rita u mmarkati bil-kodiċi 'GXEJ7' fuq naħa waħda.
English: The pack also includes a polyethylene syringe-adapter, and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Maltese: Dan il-pakkett fih ukoll adapter tal-polyethylene għassiringa, u siringa ta' 10 ml għall-għoti ta' dożi mill-ħalq magħmula minn tubu ċilindriku talpolypropylene (b'kejl ta' ml mnaqqax fuqu) u planġer tal-polyethylene.
English: It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2).
Maltese: Wieħed għandu jqis li d-dejta għar-reġimen ta' darba kuljum hija limitata ħafna f'din il-popolazzjoni (ara sezzjonijiet 4.4, 5.1 u 5.2).
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Maltese: It-terapija għandha tinbeda minn tabib ta' esperjenza fil-kura ta' l-infezzjoni HIV.
English: BOTTLE CARTON FOR ORAL SOLUTION
Maltese: TIKKETTA TAL-FLIXKUN GĦAL SOLUZZJONI ORALI
English: This difference in suppression rates between tablets and solutions remained through Week 96 with once daily dosing.
Maltese: Din id-differenza fir-rati tassoppressjoni bejn il-piloli u s-soluzzjoni baqgħet sa Ġimgħa 96 b'dożaġġ ta' darba kuljum.
English: Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47%).
Maltese: u f' Cmax aktar baxx (imnaqqas b'47%).
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Rarament ġew irrappurtati disturbi newroloġiċi li ma tfaċċawx mill-ewwel (ipertonja, aċċessjoni, imġiba mhux normali).
English: Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Maltese: Il-probabbilta' ta' interazzjonijiet metaboliċi hi baxxa minħabba l-metaboliżmu limitat, l-għaqda malproteina fil-plażma u t-tneħħija kważi totali mill-kliewi.
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesia)
Maltese: Disturbi tas-sistema nervuża Komuni: Uġigħ ta' ras, insonnja Rari ħafna:
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Maltese: Ċertament, id-data klinika disponibbli hija limitata ħafna u ma tħallix li ssir konklużjoni fil-qasam li ta' min joqgħod fuqha.
English: Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg):
Maltese: Rakkomandazzjonijiet dwar id-dożi -Adulti, adolexxenti u tfal (li jiżnu tal-inqas 25 kg) :
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Maltese: Evidenza minn studji kliniċi turi li meta lamivudine u zinovudine jittieħdu flimikien idumu aktar ma jitfaċċaw milli jitfaċċaw iżolati reżistenti għal zinovudine f'dawk li ma jkunux ħadu terapija antiretrovirali qabel.
English: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets.
Maltese: Fliexken tal-HDPE li ma jinfetħux mit-tfal jew f'pakketti b'folji tal-PVC/aluminju li jkun fihom 60 pillola kull wieħed.
English: What Epivir looks like and the contents of the pack Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets.
Maltese: Il-pilloli Epivir ta' 150 mg miksijin b'rita jiġu fi fliexken bojod tal-polyethylene jew f'folji li jkun fihom 60 pillola.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommijiethom kienu ħadu NRTIs waqt it-tqala, il-benefiċċju mill-protezzjoni kontra l-HIV kien akbar mir-riskju taleffetti sekondarji.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Maltese: Abbażi ta' aktar minn 200 par ta' omm/wild ikkurati għall-HIV, ilkonċentrazzjonijiet ta' lamivudine fis-serum fi trabi mreddgħin ta' ommijiet ikkurati għall-HIV huma baxxi ħafna (<4% tal-konċentrazzjonijiet fis-serum tal-omm) u progressivament jonqsu għal livelli mhux traċċabbli meta trabi mreddgħin jaslu fl-età ta' 24 gimgħa.
English: Children receiving lamivudine oral tablets according to the recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet formulation has higher bioavailability (see section 4.2).
Maltese: It-tfal li jirċievu pilloli orali ta' lamivudine skont irreġimen ta' dożaġġi rrakkomandat jilħqu espożizzjoni ta' lamivudine fil-plażma ogħla minn tfal li jirċievu soluzzjoni orali peress li jingħataw dożi ta' mg/kg ogħla bil-formolazzjonijiet tal-pilloli u lgħamla ta' pilloli għandha bijodisponibbiltà ogħla (ara sezzjoni 4.2).
English: Opportunistic infections: Patients receiving Epivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Maltese: Pazjenti li jkunu qed jieħdu Epivir jew xi terapija antiretrovirali oħra jistgħu ikomplu jaqbduhom infezzjonijiet opportunistiċi jew xi kumplikazzjonjiet oħra ta'linfezzjonijiet ta' l-HIV, u għalhekk għandhom jibqgħu jiġu osservati mill- qrib klinikament minn tobba ta' esperjenza fil-kura ta' pazjenti b'mard assoċjat ma' l-HIV.
English: Each film-coated tablet contains 150 mg lamivudine.
Maltese: Kull pillola miksija b'rita jkun fiha 150 mg lamivudine.
English: 3.3 mg/kg once daily
Maltese: 3.3 mg/kg darba kuljum
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul terapija antiretrovirali (ara sezzjoni 4.4).