FrancophonIA/ELRC3.0 huggingface dataset:
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: Id-dejta farmakokinetika ġiet derivata minn 3 studji farmakokinetiċi (PENTA 13, PENTA 15 u Sottostudju PK ARROW) li għalih irreġistraw tfal li għandhom inqas minn 12-il sena.
English: Children weighing ≥ 20 kg to <25 kg: The recommended dose is 225 mg daily.
Maltese: Tfal li jiżnu minn ≥ 20 kg sa <25 kg: Id-doża rakkomandata hija 225 mg kuljum.
English: Once Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Maltese: Darba Kuljum Plażma HIV-1 RNA <80 c/ml: n/N (%)
English: Children weighing at least 14 kg and less than 20 kg:
Maltese: Tfal li jiżnu tal-inqas 14 kg u inqas minn 20 kg:
English: Bottle contents: 240 ml oral solution
Maltese: Kontenut tal-flixkun: Soluzzjoni orali ta' 240 ml
English: Twice Daily N (%)
Maltese: Darbtejn Kuljum N (%)
English: When possible, avoid chronic coadministration of Epivir with medicinal products containing sorbitol or other osmotic acting polyalcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Maltese: Meta possibbli, evita l-għoti flimkien kroniku ta' Epivir ma' prodotti mediċinali li fihom sorbitol jew polialkoħol ieħor b'azzjoni ożmotika jew alkoħol monosakkaridu (eż. xylitol, mannitol, lactitol, maltitol).
English: Herts SG12 0DJ United Kingdom or
Maltese: Herts SG12 0DJ Ir-Renju Unit jew
English: Summary of Stead-State Plasma Lamivudine AUC (0-24) (µg.h/ml) and Statistical Comparisons for Once and Twice-Daily Oral Administration Across Studies
Maltese: Sommarju tal-AUC ta' Lamivudine fil-Plażma fi Stat Fiss (0-24) (µg.h/ml) u Paraguni Statistiċi għal Għoti Orali ta' Darba Kuljum u Darbtejn Kuljum fl-Istudji Kollha
English: Creatinine clearance (ml/min)
Maltese: Tneħħija ta' krejatinina (ml/min)
English: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1).
Maltese: 1206 pazjenti pedjatriċi infettati bl-HIV li kellhom bejn 3 xhur u 17-il sena ġew irreġistrati fil-Prova ARROW (COL105677), 669 minnhom ingħataw abacavir u lamivudine darba jew darbtejn kuljum (ara sezzjoni 5.1).
English: The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC, Cmax, and tmax.
Maltese: Il-pillola tal-150 mg hi bioekwivalenti u proporzjonali fid-doża għall-pillola tat -300 mg fir-rigward tal-AUC , Cmax, u tmax.
English: Although not studied, the same effect would be expected with other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol (see section 4.5)).
Maltese: Għalkemm ma ġiex studjat, huwa mistenni l-istess effett ma' polialkoħol ieħor b'azzjoni ożmotika jew alkoħol monosakkaridu (eż. xylitol, mannitol, lactitol, maltitol (ara sezzjoni 4.5)).
English: Lamivudine has been widely used as a component of antiretroviral combination therapy with other antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse transcriptase inhibitors).
Maltese: Lamivudine intuża ħafna bħala komponent ta' terapija kkombinata antiretrovirali ma' prodotti oħra antiretrovirali ta' l-istess klassi (NRTI) jew ta' klassijiet differenti (PI, non-inibituri ta' reverse transcriptase b'analogi nuklejosidi)
English: It is metabolised intracellularly to the active moiety, lamivudine 5'triphosphate.
Maltese: Jiġi metabolizzat fiċ-ċelluli għal komponent attiv, lamivudine 5'triphosphate.
English: Pregnancy
Maltese: Rabdomajalożi
English: • high doses of co-trimoxazole, an antibiotic.
Maltese: • dożi għoljin ta' co-trimoxazole, antibijotiku.
English: Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine Randomisation of ARROW with Plasma HIV-1 RNA <80 copies/ml: Subgroup Analysis by Formulation
Maltese: Proporzjonijiet ta' Individwi f'Darba Kuljum kontra Darbtejn Kuljum Abacavir+Lamivudine Randomizzazzjoni ta' ARROW bi Plasma HIV-1 RNA <80 kopji/ml: Analiżi tas-Sottogrupp permezz tal-Formulazzjoni
English: 4.6 Fertility, Pregnancy and lactation
Maltese: .6 Fertilità, tqala u Treddigħ
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Maltese: Mutanti ta' l-M184V juru suxxettibilita' mnaqqsa ħafna għal lamivudine u juru tnaqqis fil-kapaċita' replikattiva virali in vitro.
English: This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4).
Maltese: Din tista tingħata jew 150 mg (15 ml) darbtejn kuljum jew 300 mg (30 ml) darba kuljum (ara sezzjoni 4.4).
English: Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40 % increase in lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component did not interact.
Maltese: L-għoti ta' 160 mg/800 mg trimethoprim/sulphamethoxazole jirriżulta fi żjieda ta' 40% fl-espożizzjoni ta' lamivudine , minħabba l-komponent trimethoprim; ma kienx hemm interazzjonijiet mal-komponent sulphamethoxazole.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The oral solution also contains the following other ingredients: sugar (sucrose 3 g/15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavourings.
Maltese: Is-soluzzjoni orali fiha wkoll dawn is-sustanzi oħra li ġejjin: zokkor (sucrose 3 g/15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, ilma, togħmiet artifiċjali ta' frawli u ta' banana.
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Maltese: Lamivudine jiġi assorbit tajjeb mis-sistema gastrointestinali, u l-biodisponibilita` ta' lamivudine li jittieħed mill-ħalq fl-adulti hi normalment bejn it-80 u l-85%.
English: There have been reports of mitochondrial dysfunction in 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 li kienu esposti in utero u/jew wara ttwelid għall-analogi nukleosidi (ara sezzjoni 4.4).
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 µg.h/ml (18%).
Maltese: Il-medja (CV) AUC matul intervall fiddożi ta' 12-il siegħa hi 4.7 µg.h/ml (18%).
English: Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Il-kisja tar-rita: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80 Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull mL, jiġifieri essenzjalment ‘ħielsa mis-sodju'.
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations)
English: Lamivudine 8mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Maltese: Medja Ġeometrika ta' Dożaġġ ta' Darba Kuljum ta' Lamivudine 8mg/kg (95% Cl)
English: Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 5.2).
Maltese: Zidovudine ma jaffettwax ilfarmakokinetika ta' lamivudine (ara sezzjoni 5.2)
English: Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5).
Maltese: Id-doża rrakkomandata hija ta' 0.5 mL/kg (5 mg/kg) darbtejn kuljum, jew ta' 1 mL/kg (10 mg/kg) darba kuljum (ara sezzjonijiet 4.4 u 4.5).
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Maltese: Żjieda moderata ta' Cmax(28%) ġiet osservata meta zidovudine ingħata ma' lamivudine, madankollu lespożizzjoni ġenerali (AUC) ma tinbidilx b'mod sinifikanti.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Maltese: Ir-reżistenza inkroċjata li jagħti l-M184V RT hi limitata fil-grupp tal-inibituri nukleosidi ta' prodotti antiretrovirali.
English: Hypromellose (E464) Titanium dioxide (E171), Macrogol,
Maltese: Hypromellose (E464) Macrogol
English: The triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also active against zidovudine-resistant clinical isolates of HIV.
Maltese: It-triphosphate għandu attivita' inibitorja selettiva kontra r-replikazzjoni in vitro ta' l-HIV-1 u l-HIV-2, hu attiv ukoll kontra iżolati kliniċi ta' l-HIV li huma reżistenti għal zidovudine.
English: Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA >1000 copies/ml.
Maltese: Saru analiżijiet dwar ir-reżistenza ġenotipika fuq kampjuni bi plażma ta' HIV-1 RNA >1000 kopja/ml.
English: Epivir 10 mg/ml oral solution Lamivudine
Maltese: Epivir 10 mg/ml soluzzjoni orali Lamivudine
English: • high doses of co-trimoxazole, an antibiotic
Maltese: • dożi għoljin ta' co-trimoxazole, antibijotiku
English: These may affect up to 1 in 10,000 people:
Maltese: Dawn jistgħu jaffettwaw sa persuna waħda minn kull 10,000:
English: Absorption differences have been observed between adult and paediatric populations (see Special populations).
Maltese: Ġew osservati differenzi flassorbiment bejn il-popolazzjoni tal-adulti u dik pedjatrika (ara Popolazzjonijiet speċjali).
English: In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 10.31 (6.26, 17.0) µg.h/ml in the once-daily dosing and 9.24 (4.66, 18.3) µg.h/mL in the twice-daily dosing.
Maltese: Fi studju PENTA 15, il-medja ġeometrika ta' AUC ta' lamivudine fil-plażma (0-24) (95 % CI) talerba' individwi li għandhom inqas minn 12-il xahar li jeqilbu minn reġimen ta' dożaġġ ta' darbtejn kuljum għal wieħed ta' darba kuljum (ara sezzjoni 5.1) hija 10.31 (6.26, 17.0) µg.h/mL fid-dożaġġ ta' darba kuljum u 9.24 (4.66, 18.3) µg.h/ml) fid-dożaġġ ta' darbtejn kuljum.
English: Metabolism and nutrition disorders Very rare: Lactic acidosis
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari ħafna: Aċidożi lattika
English: 50 mg (5 ml)
Maltese: 50mg (5m)
English: In 60 healthy adult volunteers, Epivir 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at steady-state to Epivir 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax.
Maltese: F'60 voluntier adulti f'saħħithom, ġie stabbilit li 300 mg ta' Epivir mogħtija darba kuljum huma farmakokinetikament ekwivalenti fi stat stabbli għal 150 mg Epivir mogħtija darbtejn kuljum fir-rigward ta' triphosphate fiċċelluli AUC24 u Cmax.
English: oC.
Maltese: jew
English: Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Maltese: Lamivudine huwa analogu nukleoside li jaħdem kontra l-virus ta' l-immunodefiċjenza (HIV) u l-virus ta' l-epatite B (HBV) fil-bniedem .
English: Children weighing 14 to < 20 kg: The recommended dose is 150 mg daily.
Maltese: Tfal li jiżnu minn 14 sa < 20 kg: Id-doża rakkomandata hija 150 mg kuljum.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: From intravenous studies, the mean volume of distribution is 1.3 l/kg.
Maltese: Minn studji dwar it-teħid minn ġol-vini jirriżulta li l-volum medju ta' distribuzzjoni hu 1.3 l/kg.
English: This medicine contains 300 mg propylene glycol in each 15ml.
Maltese: Din il-mediċina fiha 300 mg ta' propylene glycol f'kull 15ml.
English: Children weighing at least 20 kg and less than 25 kg:
Maltese: Tfal li jiżnu tal-inqas 20 kg u inqas minn 25 kg:
English: Children (weighing less than 25 kg):
Maltese: Tfal (li jiżnu inqas minn 25 kg):
English: Clinical trial evidence from paediatric patients receiving lamivudine with other antiretroviral drugs (abacavir, nevirapine/efavirenz or zidovudine) has shown that the resistance profile observed in paediatric patients is similar to that observed in adults, in terms of the genotypic substitutions detected and their relative frequency.
Maltese: Evidenza ta' provi kliniċi minn pazjenti pedjatriċi li rċevew lamivudine ma' mediċini antiretrovirali oħrajn (abacavir, nevirapine/efavirenz jew zidovudine) uriet li l-profil tar-reżistenza osservat f'pazjenti pedjatriċi huwa simili għal dak osservat fl-adulti, f'termini tas-sostituzzjonijiet ġenetiċi mikxufin u lfrekwenza relattiva tagħhom.
English: Abacavir maintains its antiretroviral activities against lamivudineresistant HIV-1 harbouring only the M184V mutation.
Maltese: Abacavir iżomm l-attivitajiet antiretrovirali tiegħu kontra l-HIV-1 li jkunu jirreżistu għal lamivudine waqt li jżomm biss il-mutazzjoni M184V.
English: Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg): Creatinine clearance (ml/min)
Maltese: Rakkomandazzjonijiet dwar id-dożi - Adulti, adolexxenti u tfal (li jiżnu tal-inqas 25 kg): Tneħħija ta' krejatinina (ml/min)
English: Grey, diamond shaped and engraved with “GX EJ7” on one face
Maltese: Pillola griża, forma ta' djamant b'“GX EJ7” inċiż fuq naħa waħda
English: Epivir 150 mg tablets lamivudine
Maltese: Epivir 150 mg pilloli lamivudine
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 li l-iżvilupp ta' M184V jista' jipprovdi attivita' antiretrovirali residwa (li tista' tiġri minħabba li l-virus ma jibqax jiffunzjona sewwa).
English: Week 0 (After ≥36 Weeks on Treatment) Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Maltese: Ġimgħa 0 (Wara ≥36 Ġimgħa ta' Kura) RNA HIV-1 fil-Plażma <80 c/ml Differenza fir-riskju (darba kuljum-darbtejn kuljum)
English: 10 mg/kg or
Maltese: 10 mg/kg jew
English: These differences were observed in each different age group studied.
Maltese: Dawn id differenzi ġew osservati f'kull grupp differenti ta' età studjat.
English: Respiratory, Thoracic and mediastinal disorders Common: Cough, nasal symptoms
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni: Sogħla, sintomi fl-imnieħer
English: Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of lamivudine in plasma are 1.2 µg/ml (24%) and 0.09 µg/ml (27%), respectively.
Maltese: Ibbażat fuq informazzjoni miksuba minn studju li sar fuq voluntieri f'saħħithom, b'doża terapewtika ta' 150 gm darbtejn kuljum, Cmax medju (CV) fi stat stabbli u Cmin medju fi stat stabbli ta' lamivudine fil-plażma huma 1.2 µg/ml (24%) u 0.09 µg/ml (27%), rispettivament.
English: Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Maltese: RNA HIV-1 fil-Plażma <80 c/ml Differenza fir-riskju (darba kuljum-darbtejn kuljum)
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 lamivudine was combined with tenofovir disoproxil fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku u ta' emerġenza ta' reżistenza kmieni fl-istadju meta lamivudine kien ikkombinat ma' tenofovir disoproxil fumarate u abacavir kif ukoll ma' tenofovir disoproxil fumarate u didanosine b'sistema ta' kura ta' darba kuljum.
English: The observed half-life of elimination is 5 to 7 hours.
Maltese: Ilhalf-life ta' eliminazzjoni osservata dwar it-teħid minn ġol-vini hi ta' bejn 5 u 7 sigħat.
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 Bbażat fuq HIV-1 RNA fil-Plażma inqas minn 80 kopja/ml f'Ġimgħa 48 u Ġimgħa 96 fir-randomizzazzjoni ta' abacavir + lamivudine Darba Kuljum kontra Darbtejn Kuljum ta' ARROW (Analiżi Osservata)
English: 300 mg or
Maltese: 300 mg jew
English: Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders Rare: Rhabdomyolysis
Maltese: Disturbi muskolu-skeltali, tat-tessut konnettiv u ta' l-għadam Komuni: Artralġja, disturbi fil-muskoli Rari:
English: The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell (16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).
Maltese: Il-komponent attiv ta' lamivudine triphosphate fiċ-ċelluli għandu half-life terminali imtawwla fiċċellula (16 sa 19-il siegħa) meta mqabbel mal-half-life fil-plażma (5 sa 7 sigħat).
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 jinibixxi l-fosforizzazjoni intraċellulari ta' cladribine u b'hekk iwassal għal riskju potenzjali ta' telf tal-effikaċja ta' cladribine fil-każ li jittieħdu flimkien fl-ambjent kliniku.
English: The usual dose of Epivir is 0.5 mL/kg (5 mg/kg) twice daily (leaving approximately 12 hours between each dose), or 1 mL/kg (10 mg/kg) once daily.
Maltese: Id-doża tas-soltu ta' Epivir hija 0.5 mL/kg (5 mg/kg) darbtejn kuljum (bejn wieħed u ieħor 12-il siegħa bejn kull doża), jew 1 mL/kg (10 mg/kg) darba kuljum.
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Maltese: Meta jittieħed ma' zidovudine ikun hemm żjieda ta 13% fl-espożizzjoni ta' zidovudine u żjieda ta' 28% fl-ogħla livelli fil-plażma.
English: Other medicines and Epivir
Maltese: Mediċini oħra u Epivir
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (> 70%) via the organic cationic transport system.
Maltese: 32 l/h/kg, bi tneħħija predominanti mill-kliewi (>70%) permezz tas-sistema tat-trasport organika u katjonika.
English: EU/1/96/015/001 (Bottle) EU/1/96/015/004 (Blister pack)
Maltese: EU/1/96/015/004 (Pakkett bil-folji)
English: • Lactic acidosis (excess lactic acid in the blood)
Maltese: • Aċidożi lattika (aċidu lattiku żejjed fid-demm)
English: Date of first authorisation: 8 August 1996 Date of last renewal: 28 July 2006
Maltese: Data tal-aħħar tiġdid: 28 ta' Lulju 2006
English: HDPE bottles :
Maltese: Fliexken tal-HDPE:
English: Epivir 300 mg tablet lamivudine
Maltese: Epivir 300 mg pilloli lamivudine
English: Adults, adolescents and children who weigh at least 25 kg:
Maltese: Adulti, adolexxenti u tfal li jiżnu tal-inqas 25 kg:
English: • headache
Maltese: Epatite
English: Do not store above 30°C
Maltese: Taħżnux f'temperatura 'l fuq minn 30°C
English: The usual dose of Epivir is 225 mg a day.
Maltese: Id-doża tas-soltu ta' Epivir hija 225 mg kuljum.
English: The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Maltese: Il- proporzjon medju ta' CSF/konċentrazzjoni ta' lamivudine fis-serum 2-4 sigħat wara t-teħid mill-ħalq kienet ta' madwar 0.12.
English: The combination of lamivudine with cladribine is not-recommended (see section 4.5).
Maltese: It-taħlita ta' lamivudine ma' cladribine mhix irrakkomandata (ara sezzjoni 4.5).
English: Uncommon side effects These may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Maltese: Interazzjoni ma' trimethropim, kostitwent ta' co-trimoxazole , tikkawża Żjieda ta' 40% fl-espożizzjoni ta' lamivudine f'dożi terapewtiċi.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in lamivudine exposure at therapeutic doses.
Maltese: Interazzjoni ma' trimethropim, kostitwent ta' co-trimoxazole , tikkawża żjieda ta' 40% fl-espożizzjoni ta' lamivudine f'dożi terapewtiċi.
English: Film-coated tablets:
Maltese: Disfunzjoni tal-mitokondrija:
English: Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in paediatric patients below 12 years of age.
Maltese: Tfal: Il-bijodisponibbiltà assoluta ta' lamivudine (madwar 58-66 %) kienet inqas f'pazjenti pedjatriċi li kellhom inqas minn 12-il sena.
English: How to store Epivir
Maltese: Tiħux Epivir:
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħta Komuni: Raxx, alopeċja Rari:
English: Tablet film-coat:
Maltese: Popolazzjoni pedjatrika:
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 16% - 36% to serum albumin in in vitro studies).
Maltese: (<16% - 36% għall-albumin tas-serum fi studji in vitro).
English: Date of first authorisation: 15 November 2001 Date of last renewal: 28 July 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2001
English: Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily.
Maltese: Id-doża rrakkomandata hija ta' 0.5 mL/kg (5 mg/kg) darbtejn kuljum.
English: Adults, adolescents and children weighing at least 25 kg The usual dose of Epivir is 30 ml (300 mg) a day.
Maltese: Adulti, adoloxxenti u tfal li jiżnu tal-inqas 25 kg Id-doża tas-soltu ta' Epivir hija 30 ml (300 mg) kuljum.
English: EU/1/96/015/003 (Bottle) EU/1/96/015/005 (Blister pack)
Maltese: Epivir 300 mg pilloli miksijin b'rita EU/1/96/015/003 (Flixkun) EU/1/96/015/005 (Pakkett bil-folji)
English: Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Maltese: Irrepeti l-proċedura minn numru 3 sa 7 bl-istess mod sakemm tieħu d-doża kollha.
English: • other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
Maltese: • emtricitabine (jintuża biex jikkura infezzjoni bl-HIV)
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Maltese: Informazzjoni limitata turu li lamivudine jidħol fis-sistema nervuża ċentrali u jilħaq il-fluwidu ċerebro-spinali (CSF).
English: Children receiving lamivudine oral solution concomitantly with other antiretroviral oral solutions in clinical trials developed viral resistance more frequently than children receiving tablets (see the description of the clinical experience in paediatric population (ARROW study) and section 5.2).
Maltese: Tfal li rċevew is-soluzzjoni orali ta' lamivudine b'mod konkomitanti ma' soluzzjonijiet orali antiretrovirali oħrajn fi provi kliniċi żviluppaw reżistenza virali iktar ta' spiss mit-tfal li rċevew ilpilloli (ara d-deskrizzjoni tal-esperjenza klinika fil-popolazzjoni pedjatrika (studju ARROW) u sezzjoni 5.2).