qanastek/EMEA-V3 huggingface dataset:
Triple nucleoside therapy:
Terapija triplika bin- nukleosidi:
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.
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.
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.
Pazjenti li jkunu qed jieħdu Epivir jew xi terapija antiretrovirali oħra jistgħu ikomplu jaqbduhom infezzjonijiet opportunistiċi jew xi kumplikazzjonjiet oħra ta’ l -
14 Transmission of HIV:
14 infezzjonijiet 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.
Patients should be advised that current antiretroviral therapy, including Epivir, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Il- pazjenti għandhom jitwissew li t- terapija antiretrovirali li hemm bħal issa, inkluż Epivir, ma ġietx pruvata li tneħħi r- riskju li l- HIV tittieħed minn kuntatt sesswali jew minn kontaminazzjoni bid- demm.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Dan it- tagħrif m’ għandux jafettwa r - rakkomandazzjonijiet kurrenti għall- użu tat- terapija antiretrovirali għall- prevenzjoni tat- transmissjoni vertikali ta ’ l- HIV f’ nisa tqal.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Lipodistrofija: It- terapija kombinata antiretrovirali ġiet asoċjata ma 'distribuzzjoni mill- ġdid tax- xaħam tal- ġisem (lipodistrofija) f' pazjenti bl- HIV.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Konnessjoni bejn lipomatożi tal- vixxri u inibituri tal- protease (Pis) u lipoatrofija u inibitiri ta ’ reverse transcriptase b’ analogi nuklejosidi (NRTIs) ġiet meħuda bħala ipotesi.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju ogħla ta 'lipodistrofija ġie assoċjat ma' fatturi individwali bħal eta 'aktar avanzata, u ma' fatturi relatati ma 'mediċini bħal kura antiretrovirali aktar fit- tul u disturbi metaboliċi relatati.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jiġi meqjus il- kejl tal - lipidi fis- serum waqt is- sawm u tal - glukosju fid- demm.
Immune Reactivation Syndrome:
15 Sindromu ta ’ Rijattivazzjoni Immunitarja:
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or 15 aggravation of symptoms.
F’ pazjenti infettati bl- HIV, b’ defiċjenza immunitarja severa fiż- żmien li tkun inbdiet it- terapija antiretrovirali kombinata (CART), jista ’ jkun hemm reazzjoni infjammatorja għall- mikrobi opportunistiċi moħbija jew residwi li jwasslu għall- kundizzjonijiet kliniċi serji jew li sintomi jmorru għall- agħar.
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).
Jekk Epivir jitwaqqaf f' pazjenti ko- infettati bil- virus ta 'l- epatite B, huwa rakkomandat 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).
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Jekk f' dawn il- pazjenti jidhru xi sinjali li l - mard tal- fwied ikun sejjer għall- agħar, għandha tiġi kkunsidrata l- interruzzjoni jew it- twaqqif tal- kura (ara taqsima 4. 8).
Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Pazjenti dijabetiċi għandhom ikunu mwissija li kull doża (150mg =15ml) fiha 3g ta ’ sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi rari ereditarji ta ’ ntolleranza ta ’ fructose, ħdim ħażin ta ’ glukosju- galactose mill - musrana ż- żgħira jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Epivir contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Epivir fih methyl parahydroxybenzoate u propyl parahydroxybenzoate.
These may cause allergic reactions (possibly delayed).
Dan jistgħu jikkawżaw reazzjonijiet allerġiċi.
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.
L- għoti ta ’ 160 mg/ 800 mg trimethoprim/ sulphamethoxazole jirriżulta f' Żjieda ta '40% fl- espożizzjoni ta ’ lamivudine, minħabba l- komponent trimethoprim; Ma kienx hemm interazzjonijiet mal -
Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Lamivudine m' għandu l- ebda effett fuq il- farmakokinetiċi ta’ trimethoprim jew ta ’ sulphamethoxazole.
16 The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e. g. trimethoprim.
Il- possibbilta ’ ta 'nuqqas ta' interazzjonijiet ma 'prodotti mediċinali oħra li jingħataw fl- istess ħin għandha tiġi kkunsidrata, partikolarment meta r- rotta ewlenija tat- tneħħija tkun is- sekrezzjoni attiva mill- kliewi permezz tas- sistema tat- trasport organika u ketajonika ta' trasport e. ż trimethoprim.
Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000).
Il- frekwenzi huma definiti bħala komuni ħafna (> 1/ 10), komuni (< 1/ 100, < 1/ 10), mhux komuni (> 1/ 1, 000, < 1/ 100), rari (> 1/ 10, 000, < 1/ 1, 000), rari ħafna (< 1/ 10, 000 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Blood and lymphatic systems disorders Uncommon:
17 Disturbi tad- demm u tas- sistema limfatika Mhux komuni:
Pure red cell aplasia
Aplasija pura ta ċ- ċelluli l- ħomor
Peripheral neuropathy (or paraesthesia)
Newropatija periferali (jew parasteżja).
17 Gastrointestinal disorders Common:
Disturbi gastro- intestinali Komuni:
Pancreatitis elevations in serum amylase.
Pankreatite, żjidiet fl- amylase tas- serum.
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
It terapija antiretrovirali kombinata ġiet assoċjata ma 'distribuzzjoni mill- ġdid tax- xaħam tal- ġisem (lipodistrofija) f' pazjenti bl- HIV inkluż it- tnaqqis ta' xaħam taħt il- ġilda periferali u tal- wiċċ, Żjieda ta 'xaħam intra- addominali u vixxerali, ipertrofija tas- sider u akkumulazzjoni ta' xaħam dorsoċervikali (buffalo hump).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART).
Każijet ta ’ nekrożi fl- għadam instab li huwa partikolarment aktar komuni f’ pazjenti b’ fatturi ta ’ riskju magħrufa, b’ HIVavvanzat jew użu ta ’ terapija antiretrovirali kombinata (CART) fit- tul.
Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
Fi studji akuti dwar annimali l- għoti ta’ lamivudine f' livelli ta 'dożi għolja ħafna ma rriżultax f' tossiċita' ta 'l- organi.
Limited data are available on the consequences of ingestion of acute overdoses in humans.
L- informazzjoni limitati huma disponibbli dwar il- konsegwenzi ta 'inġestjoni ta' dożi eċċessivi akuti fil- bniedem hija limitata.
If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
18 Fil- każ ta 'doża eċċessiva il- pazjent għandu jkun monitorjat, u għandu jingħata l- għajnuna permezz tal - kura standard li jkun hemm bżonn.
Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied.
Billi l- lamivudine jista 'jiġi dijalisizzat, dijalisi kontinwa tad - demm tista' tiġi użata fil- kura ta 'doża eċċessiva, għalkemm din ma ġietx studjata.
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.
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.
M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Mutanti ta 'l- M184V juru suxxettibilta' mnaqqsa ħafna għal- lamivudine u juru tnaqqis fil- kapaċita 'replikattiva virali in vitro imnaqqsa.
Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Ċertament, id- data klinika disponibbli hija limitata ħafna u ma tħallix li ssir konklużzjoni fil- qasam li ta ’ min joqgħod fuqha.
Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Zidovudine u Stavudine iżommu l- attivitajiet antiretrovirali tagħhom kontra l- HIV- 1 li jkunu reżistenti għal- lamivudine.
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).
19 Lamivudine intuża ħafna bħala komponent ta 'terapija kombinata antiretrovirali ma' prodotti oħra antiretrovirali ta 'l- istess klassi (NRTI) jew ta' klassijiet differenti (PI, non- inibituri ta ’ reverse transcriptase b’ analogi nuklejosidi)
However, for the treatment of HIV infection, only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Madankollu, għall- kura ta 'l- infezzjoni HIV doża ta' 300 mg kuljum ta 'lavimudine biss (flimkien ma' prodotti oħra antiretrovirali) irriżulta li kienet effikaċi.
19 Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Lamivudine ma ġiex investigat speċifikament f' pazjenti bl- HIV ko- infettati bl- HBV.
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.
Doża ta 'darba kuljum (300 mg darba kuljum): studju kliniku wera li m' hemmx inferjorita' bejn it - teħid ta 'Epivir darba kuljum u Epivir darbtejn kuljum.
These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Dawn ir- riżultati nkisbu minn popolazzjoni inġenwa antiretrovirali, li kienet tikkonsisti prinċipalment f' pazjenti infettati bl- HIV li ma għandhomx sintomi (CDC stadju A).
Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Meta jittieħed ma - zidovudine ikun hemm żjieda ta 13% fl- espożizzjoni ta ’ zidovudine u f' żjieda ta '28% fl- ogħla livelli fil- plażma.
Limited data show that lamivudine penetrates the central nervous system and reaches the cerebro- spinal fluid (CSF).
Informazzjoni limitata turu li lamivudine jidħol fis- sistema nervuża ċentrali u jilħaq il- fluwidu ċerebro- spinali (CSF).
Lamivudine is predominately cleared unchanged by renal excretion.
20 Il- biċċa l- kbira ta ’ lamivudine jitneħħa mill- ġisem mingħajr ma jinbidel permezz ta ’ sekrezzjoni mill - kliewi.
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a40% increase in lamivudine exposure at therapeutic doses.
Interazzjoni ma 'trimethropim, kostitwent ta ’ co- trimoxazole, tikkawża Żjieda ta' 40% fl- espożizzjoni ta ’ lamivudine f' dożi terapewtiċi.
20 Pharmacokinetics in children:
Farmakokinetiċi fit- tfal:
Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/ kg twice daily.
Minħabba dawn id- differenzi, id- doża ta ’ lamivudine rakkomandata għal tfal (ta 'aktar minn tlett xhur u li jiżnu anqas minn 30kg) hi ta' 4 mg/ kg / darbtejn kuljum.
Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
L- għoti tal- lamivudine f' dożi qawwija fi studji dwar tossiċita 'ta' l- annimali ma ġiex assoċjat ma 'xi tossiċita' għolja ta 'organi.
At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Fl- ogħla livelli ta 'dożaġġi, dehru xi effetti żgħar fuq indikaturi tal - funzjonament tal- fwied u l- kliewi kultant flimkien ma' tnaqqis fil- piż tal- fwied.
The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
L- effetti kliniċi relevanti li ġew osservati kienu tnaqqis ta 'l- għadd ta' ċelluli ħomor u newtropenja.
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.
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.
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Lamivudine ma kienx ġenotossiku in vivo f' dożi li pproduċew konċentrazzjonijiet fil- plażma ta 'madwar 40- 50 darba aktar mill- livelli kliniċi ta' plażma imbassra.
As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Billi l- attivita 'mutaġenika in vitro ta’ lamivudine ma setgħetx tiġi konfermata f' testijiet in vivo, ġie konkluż li lamivudine m' għandux jiġi meqjus ta' periklu ġenotossiku f' pazjenti li jkunu qed jieħdu t- trattament.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue- DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
L- istudju wera li feti esposti in utero għat - taħlita sostnew livelli għola ta ’ inkorporazzjoni fid- DNA ta ’ analogi tan- nukleosidi f’ ħafna mill - organi tal- fetu, u wrew evidenza ta ’ aktar tqassir ta ’ telomere minn dawk esposti għal zidovudine waħdu.
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans.
21 Ir- riżultati ta 'studji fit- tul dwar il- karċinoġeniċita ’ fuq firien u ġrieden ma wrew ebda potenzjal karċinoġeniku relevanti għall- bniedem.
PHARMACEUTICAL PARTICULARS
Tagħrif farmaċewtiku
Sucrose 20% (3 g/ 15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate Artificial strawberry flavour Artificial banana flavour
Sucrose 20% (3g/ 15ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid anhydrous Propylene glycol Sodium citrate Togħma artifiċjali ta 'frawli Togħm artifiċjali ta' banana Ilma purifikat
Discard the oral solution one month after first opening.
Armi s- soluzzjoni li tittieħed mill- ħalq xahar wara li tinfetaħ
Do not store above 25°C.
Taħżinx f' temperatura ‘ l fuq minn 25°C
Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure.
Kaxex li jkun fihom 240 ml ta 'soluzzjonifi flixkun abjad tal- polietilin ta' densita 'għolja (HDPE), li jingħalaq bla periklu jekk jiġi f' idejn it- tfal.
The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral solution.
Siringa għad- dożaġġ mill- ħalq tingħata għall- kejl tajjeb tad- doża preskritta tat- soluzzjoni.
Instructions for use are included in the pack.
Tagħrif għall- użu ikun qiegħed fil- pakkett.
No special requirements.
L- ebda ħtiġijiet speċjali
MARKETING AUTHORISATION HOLDER
DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER
NUMRU TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
Epivir 300 mg film-coated tablets
Epivir 300 mg pilloli miksija b' rita
Each film-coated tablet contains 300 mg lamivudine.
Kull pillola miksija b' rita jkun fiha 300 mg lamivudine.
For a full list of excipients, see section 6.1.
Għal lista sħiħa sustanzi mhux attivi ara taqsima 6. 1
Grey, diamond shaped and engraved with “ GX EJ7” on one face.
Griża,, għandha forma ta 'djamant u b ’ “ GX EJ7 "inċiż fuq naħa waħda.
Adults and adolescents over 12 years of age: the recommended dose of Epivir is 300 mg daily.
Adulti u adolexxenti 'il fuq minn 12- il sena: id- doża rakkomandata ta' Epivir hi ta '300 mg kuljum.
This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4).
Din tista tingħata jew 150 mg darbtejn kuljum jew 300 mg darba kuljum (ara taqsima 4. 4).
The 300 mg tablet is only suitable for the once a day regimen.
Il- pillola tat- 300 mg qiegħda hemm biss għat- trattament ta 'darba kuljum.
Patients changing to the once daily regimen should take 150 mg twice a day and switch to 300 mg once a day the following morning.
Pazjenti li jaqilbu għat- trattament ta 'darba kuljum għandhom jieħdu 150 mg darbtejn f’ ġurnata u jaqilbu għal 300 mg darba kuljum l- għada filgħodu.
Where an evening once daily regimen is preferred, 150 mg of Epivir should be taken on the first morning only, followed by 300 mg in the evening.
Meta wieħed jippreferixxi trattament ta 'darba kuljum filgħaxija, għandu jittieħu 150 mg Epivir fl- ewwel għodwa biss, imbagħad 300 mg filgħaxija.
When changing back to a twice daily regimen patients should complete the days treatment and start 150 mg twice a day the following morning.
Meta pazjenti jerġgħu lura għal trattament ta 'darbtejn kuljum dawn għandhom ikomplu l- kura tal - ġurnata imbagħad jibdew jieħdu 150 mg kuljum mill- għada filgħodu.
Less than three months of age: the limited data available are insufficient to propose specific dosage recommendations (see section 5.2)
L- informazzjoni disponibbli hija limitata u mhix biżżejjed biex wieħed jirrakkomanda xi dożaġġ speċifiku (ara taqsima 5. 2).
23 Renal impairment:
24 Indeboliment tal- kliewi -:
Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance.
Il- konċentrazzjonijiet ta ’ lamivudine jiżdiedu f' pazjenti b' indeboliment moderat jew sever tal- kliewi minħabba nuqqas ta 'tneħħija mill- ġisem.
≥ 50 30- < 50
≥50 30 - < 50 < 30
mg twice daily mg once daily
150 mg 150 mg Billi huma meħtieġa dożi ta 'inqas minn soluzzjoni orali
< 30 As doses below 150 mg are needed the use of the oral solution is recommended
150 mg darbtejn kuljum 150 mg darba kuljum 150 mg hu rakkomandat l- użu ta ’
Dosing recommendations – Children from 3 months to 12 years:
Rakkomandazzjonijiet dwar id- dożi - Tfal minn 3 xhur sa 12- il sena:
Hepatic Impairment:
Indeboliment tal- fwied:
4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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.
Pazjenti li jkunu qed jieħdu l- Epivir jew xi terapija antiretrovirali oħra jistgħu ikomplu jaqbduhom infezzjonijiet opportunistiċi jew xi kumplikazzjonjiet oħra ta’ l - infezzjonijiet 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.
24 Transmission of HIV:
25 Tixrid ta ’ HIV:
Lactic acidosis generally occurred after a few or several months of treatment.
L- aċidożi lattika ġeneralment tfaċċat wara trattament ta 'ftit xhur jew iżjed.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
It- trattament bl- analogi nuklejosidi għandu jitwaqqaf malli jidhru hyperlactatemia sintomatika u aċidożi lattika, metabolika, epatomegalija progressiva, jew żjieda ta 'malajr fil- livelli ta' l - aminotransferase.
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Pazjenti ko- infettati bl- epatite C u li jkunu fuq trattament bl- alpha interferon u ribavirin jistgħu jkunu f' riskju speċjali.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
F’ pazjenti infettati bl- HIV, b’ defiċjenza immunitarja severa fiż- żmien li tkun inbdiet it- terapija antiretrovirali kombinata (CART), jista ’ jkun hemm reazzjoni 26 infjammatorja għall- mikrobi opportunistiċi moħbija jew residwi li jwasslu għall- kundizzjonijiet kliniċi serji jew li sintomi jmorru għall- agħar.
Relevant examples are cytomegalovirus retinitis, generalised and/ or 25 focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti jinkludu retinite b’ cytomegalovirus, infezzjonijiet lokali jew mifruxa b’ mycobacterium, u pnewmonja b’ Pneumocvstis carinii.
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.
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 kombinata antiretrovirali, u għandhom ikunu monitorjati skond il- prattika standard.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Jekk f' dawn il- pazjenti jidhru xi sinjali li l - mard tal- fwied ikun sejjer għall- agħar, għandha tiġi kkunsidrata l- interruzzjoni jew it- twaqqif tat - trattament (ara sezzjoni 4. 8).
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.
L- għoti ta ’ 160 mg/ 800 mg trimethoprim/ sulphamethoxazole jirriżulta f' Żjieda ta '40% fl- espożizzjoni ta ’ lamivudine, minħabba l- komponent trimethoprim; Ma kienx hemm interazzjonijiet mal - komponent sulphamethoxazole.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e. g. trimethoprim.
Il- possibbilta ’ ta 'nuqqas ta' interazzjonijiet ma 'prodotti mediċinali oħra li jingħataw fl- istess ħin għandha tiġi kkunsidrata, partikolarment meta r- rotta ewlenija tat- tneħħija tkun is- sekrezzjoni attiva mill- kliewi permezz tas- sistema tat- trasport organika u ketajonika ta' trasport e. ż trimethoprim.
Other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
27 Prodotti mediċinali oħra (e. ż ranitidine, cimetidine) jitneħħew biss parzjalment b' dan il- mekkaniżmu u ntwera li ma hemmx interazzjonijiet ma ’ lamivudine.
26 A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Żjieda moderata ta 'Cmax( 28%) ġiet osservata meta zidovudine ingħata ma ’ lamivudine, madankollu l - espożizzjoni ġenerali (AUC) ma tinbidilx b' mod sinifikanti.
The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Ir- reazzjonijiet avversi meqjusa li huma għallinqas possibbilment relatati mat- trattament huma elenkati hawn taħt skond is- sistema tal- ġisem, il- klassi tal- organu u l- frekwenza assoluta.
Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000).
Il- frekwenzi huma definiti bħala komuni ħafna (> 1/ 10), komuni (< 1/ 100, < 1/ 10), mhux komuni (> 1/ 1, 000, < 1/ 100), rari (> 1/ 10, 000, < 1/ 1, 000), rari ħafna (< 1/ 10, 000).
Gastrointestinal disorders Common:
28 Disturbi gastro- intestinali Komuni:
Elevations in serum amylase.
Pankreatite, żjidiet fl- amylase tas- serum.
27 Skin and subcutaneous tissue disorders Common:
Disturbi fil- ġilda u fit- tessuti ta ’ taħta Komuni:
If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
Fil- każ ta 'doża eċċessiva il- pazjent għandu jkun monitorjat, u għandu jingħata l- għajnuna permezz tal - kura standard li jkun hemm bżonn.
Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied.
Billi lamivudine jista 'jiġi dijalisizzat, dijalisi kontinwa tad- demm tista' tiġi użata fit- trattament ta 'doża eċċessiva, għalkemm din ma ġietx studjata.
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
29 Lamivudine huwa analogu nukleoside li jaħdem kontra l- virus ta 'l- immunodefiċjenza (HIV) u l- virus ta' l- epatite B (HBV) fil- bniedem.
It is metabolised intracellularly to the active moiety, lamivudine 5’ - triphosphate.
Jiġi metabolizzat fiċ- ċelluli għal komponent attiv, lamivudine 5 '- triphosphate.
This variant arises both in vitro and in HIV-1
Ir- reżistenza ta ’ HIV- 1 għal lamivudine tinvolvi l- iżvilupp ta 'bidla fl- aċidu amino M184V qrib is- sit attiv tar - reverse transcriptase tal- virus (RT).
28 infected patients treated with lamivudine-containing antiretroviral therapy.
Dan il- varjant joħroġ kemm in vitro kif ukoll f' pazjenti infettati bl- HIV- 1 li jkunu fuq terapija antiretrovirali li jkun fiha lamivudine.
Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Zidovudine u Stavudine iżommu l- attivitajiet antiretrovirali tagħhom kontra l- HIV- 1 li jkun reżistenti għal lamivudine.
Abacavir maintains its antiretroviral activities against lamivudine- resistant HIV-1 harbouring only the M184V mutation.
Abacavir iżomm l- attivitajiet antiretrovirali tiegħu kontra l- HIV- 1 li jkunu jirreżistu lamivudine waqt li jżomm biss il- mutazzjoni M184V.
In vitro susceptibility testing has not been standardised and results may vary according to methodological factors.
It- testjar tas- suxxettibilta 'in vitro ma ġiex standardizzat u r- riżultati jistgħu ivarjaw skond fatturi metodoloġiċi.
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).
Lamivudine intuża ħafna bħala komponent ta 'terapija kombinata antiretrovirali ma' prodotti oħra antiretrovirali ta 'l- istess klassi (NRTI) jew ta' klassijiet differenti (PI, non- inibituri ta ’ reverse transcriptase b’ analogi nuklejosidi)
Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of adult patients with chronic HBV infection (for details of clinical studies, see the prescribing information for Zeffix).
30 Lamivudine f' doża ta '100 mg kuljum wera wkoll li hu effettiv fit- trattament ta' pazjenti adulti li jbatu minn infezzjoni kronika ta 'l- HBV (għad- dettalji ta' l- istudji kliniċi, ara t- tagħrif għall- preskrizzjoni ta’ Zeffix).
However, for the treatment of HIV infection, only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Madankollu, għat- trattament ta 'l- infezzjoni HIV doża ta' 300 mg kuljum ta 'lavimudine biss (flimkien ma' prodotti oħra antiretrovirali) irriżulta li kienet effikaċi.
29 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC∞, Cmax, and tmax.
Il- pillola tal- 150 mg hi bioekwivalenti u proporzjonali fid- doża għall- pillola tat - 300 mg fir- rigward tal- AUC∞, Cmax, u Tmax.
Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47%).
Meta lamivudine jingħata ma 'l- ikel dan jirriżulta f' dewmien tat- Tmax. u f' Cmax aktar baxx (imnaqqas b' 47%).
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.
31 farmakokinetikament ekwivalenti fi stat stabbli għal 150 mg Epivir mogħtija darbtejn kuljum fir - rigward ta 'triphosphate fiċ- ċelluli AUC24 u Cmax.
30 Pharmacokinetics in children:
Farmakokinetiċi fit- tfal:
This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng. h/ ml.
Minħabba dawn id- differenzi, id- doża rakkomandata ta ’ lamivudine fit- tfal (ta 'aktar minn tlett xhur u li jiżnu anqas minn 30kg) hi ta' 4 mg/ kg / darbtejn kuljum. Din id- doża tikseb AUC 0- 12 medja minn bejn wieħed u ieħor 3, 800 sa 5, 300 ng. h/ ml.
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
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.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue- DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
32 mill- organi tal- fetu, u wrew evidenza ta ’ aktar tqassir ta ’ telomere minn dawk esposti għal zidovudine waħdu.
Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
Microcrystalline cellulose (E460) Sodium starch glycollate Magnesium Stearate
Hypromellose (E464),
Ir- rita tal- pillola:
31 Titanium dioxide (E171), Black iron oxide (E172), Macrogol, Polysorbate 80
Hypromellose (E464) Macrogol Polysorbate 80
Not applicable
Ma jgħoddx f' dan il- każ
PVC/ aluminium foil blister packs:
Pakketti b' folji ta 'PVC/ aluminju sentejn
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dawk li hemm ġo fih
Child resistant HDPE bottles or PVC/ aluminium foil blister packs each containing 30 tablets.
Fliexken HDPE li ma jinfetħux mit- tfal jew f' pakketti b' folji tal- PVC/ aluminju li jkun fihom 30 pillola kull wieħed.
EU/ 1/ 96/ 015/ 003 (Bottle) EU/ 1/ 96/ 015/ 005 (Blister pack)
EU/ 1/ 96/ 015/ 003 (Flixkun)
15 November 2001 Date of last renewal:
15 ta 'Novembru, 2001 Data ta ’ l- aħħar tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
32 ANNEX II
34 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT B.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Film-coated tablets:
Pilloli miksijin b’ rita:
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street, Ware Hertfordshire SG12 0DJ United Kingdom.
Glaxo Operations UK Limited (fil- kummerċ Glaxo Wellcome Operations) Priory Street, Ware Hertfordshire SG12 0DJ Renju Unit.
Oral solution:
Soluzzjoni li tittieħed mill- ħalq:
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
KG Industriestrasse 32- 36 23843 Bad Oldesloe Germanja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli għall- ħruġ tal- lott konċernat.
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, section 4.2)
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2)
• OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA PSUR:
The Marketing Authorisation Holder will have to submit PSURs on a yearly basis.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ikollu jissottometti PSUR kull sena.
34 ANNEX III
36 ANNESS III
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE CARTON X 60 FILM-COATED TABLETS (150 mg)
KARTUNA BI FLIXKUN X 60 PILLOLA MIKSIJIN B' RITA (150 mg)
Epivir 150 mg film-coated tablets Lamivudine
Epivir 150 mg pilloli miksijin b' rita Lamivudine
Each film-coated tablet contains lamivudine 150 mg
Kull pillola miksija b' rita fiha lamivudine 150 mg
PHARMACEUTICAL FORM AND CONTENTS
ĠĦAMLA FARMAĊEWTIKA U KONTENUT
60 film-coated tablets Scored tablets
60 pillola miksijin b' rita Pilloli b’ marka biex taqsamha minn nofs
EXP {MM/ YYYY}
XX/ SSSS
Do not store above 30°C
Taħżinx f' temperatura ta '‘ l fuq minn 30°C
LOT
Lott:
epivir 150 mg
epivir 150mg
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL X 60 FILM-COATED TABLETS (150 mg)
TIKKETTA TA ’ FUQ IL- FLIXKUN X 60 PILLOLA MIKSIJIN B' RITA (150 mg)
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
BLISTER CARTON X 60 FILM-COATED TABLETS (150 mg)
KARTUNA B’ FOLJI X 60 PILLOLA MIKSIJIN B' RITA (150 mg)
60 film-coated tablets
60 pillola miksijin b' rita
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Epivir 150 mg tablets
Epivir 150 mg pilloli
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
LOT
LOTT
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE CARTON FOR ORAL SOLUTION
KARTUNA TAL- FLIXKUN GĦAL SOLUZZJONI ORALI
Epivir 10 mg/ ml oral solution Lamivudine
Epivir 10 mg/ ml soluzzjoni orali Lamivudine
Each ml of oral solution contains 10 mg lamivudine
Kull ml ta ’ soluzzjoni orali fiha 10 mg lamivudine
This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl parahydroxybenzoate
Dan il- prodott fih ukoll zokkor, priservattivi: methyl parahydroxybenzoate u propyl parahydroxybenzoate
Bottle contents:
Kontenut tal- flixkun:
240 ml oral solution
Soluzzjoni ta 240 ml
Keep out of the reach and sight of children.
Żommu fejn tfal ma jintlaħaqx u ma jidhirx mit- tfal
Do not store above 25°C
Taħżinx f' temperatura ta '‘ l fuq minn 25°C
Discard one month after first opening
Armih xahar wara li jinfetaħ l- ewwel darba
epivir 10 mg/ ml
epivir 10mg/ ml
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL FOR ORAL SOLUTION
TIKKETTA TAL- FLIXKUN GĦAL SOLUZZJONI ORALI
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE CARTON X 30 FILM-COATED TABLETS (300 mg)
KARTUNA TAL- FLIXKUN X 30 PILLOLA MIKSIJIN B’ RITA (300mg)
Epivir 300 mg film-coated tablets Lamivudine
Epivir 300mg pilloli miksijin b’ rita Lamivudine
Each film-coated tablet contains Lamivudine 300 mg
Kull pillola miksija b’ rita fiha Lamivudine 300mg
30 film-coated tablets
30 pillola miksijin b’ rita
epivir 300 mg
Epivir 300mg
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL X 30 FILM-COATED TABLETS (300 mg)
KARTUNA TAL- FLIXKUN X 30 PILLOLA MIKSIJIN B’ RITA (300mg)
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
BLISTER CARTON X 30 FILM-COATED TABLETS (300 mg)
KARTUNA B’ FOLJI X 30 PILLOLA MIKSIJIN B' RITA (300 mg)
NAME OF THE MEDICINAL PRODUCT
ISEM IL- PRODOTT MEDIĊINALI
Epivir 300 mg film-coated tablets Lamivudine
Epivir 300 mg Pilloli miksijin b' rita Lamivudine
Each film-coated tablet contains lamivudine 300 mg
Kull pillola miksija b' rita fiha lamivudine300 mg
30 film-coated tablets
30 pillola miksijin b' rita
Keep out of the reach and sight of children.
Żommu fejn ma jinlaħaqx u ma jidhirx mit- tfal
epivir 300 mg
epivir 300mg
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Epivir 300 mg tablet
Epivir 300 mg pilloli
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel ma 'tibda tieħu din il- mediċina.
You may need to read it again.
Jista 'jkollok bżonn terġa' taqrah
- This medicine has been prescribed for you.
Din il- mediċina ġiet mogħtija lilek.
even if their symptoms are the same as yours
M’ għandekx tgħaddiha lil persuni oħra. Tista 'tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Epivir is and what it is used for 2.
X' inhu l- Epivir u għalxiex jintuża 2.
Before you take Epivir 3.
Qabel ma tieħu Epivir 3.
How to take Epivir 4.
Kif għandek tieħu Epivir 4.
Possible side effects 5.
X' effetti oħra jista 'jkollu 5.
How to store Epivir 6.
Kif taħżen Epivir 6.
WHAT EPIVIR IS AND WHAT IT IS USED FOR
X' INHU EPIVIR U GĦALXIEX JINTUŻA
Epivir belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Epivir jagħmel parti minn grupp ta 'mediċini antivirali, magħrufin ukoll bħala antiretrovirali, li jissejħu inibituri tar- reverse transcriptase b’ analogi nuklejosidi( NRTI).
These are used to treat Human Immunodeficiency Virus (HIV) infection.
Dawn jintużaw għall- kura ta 'l - infezzjoni mill- Virus ta' l- Immunodefiċjenza fil- Bniedem (HIV).
Epivir is used in antiretroviral combination therapy for the treatment of HIV infection in adults and children.
Epivir jintuża fit- terapija kombinata antiretrovirali għall- kura ta 'l- infezzjoni HIV fl- adulti u fit- tfal.
Epivir reduces the amount of HIV virus in your body, and keeps it at a low level.
Epivir inaqqas l- ammont ta 'virus ta' l- HIV fil- ġisem, u jżommu f' livell baxx.
It also increases CD4 cell counts.
Iżid ukoll l- għadd taċ - ċelluli CD4.
CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection.
Iċ- ċelluli CD4 huma tip ta 'ċelluli bojod tad- demm, li huma importanti biex iżommu ta' sistema immuni b' saħħitha għall- ġlieda kontra l- infezzjoni.
Response to treatment with Epivir varies between patients.
Ir- reazzjoni għall- kura bl- Epivir tvarja bejn pazjent u ieħor.
Your doctor will be monitoring the effectiveness of your treatment.
It- tabib tiegħek jeżamina l- effett tal- kura tiegħek.
BEFORE YOU TAKE EPIVIR
QABEL MA TIEĦU EPIVIR
Do not take Epivir
Tieħux Epivir:
- if you are allergic (hypersensitive) to lamivudine or any of the other ingredients found in
- jekk inti allerġiku (tbati minn sensittivita 'eċċessiva) għal lamivudine jew għal xi wieħed mis -
Epivir tablets.
sustanzi l- oħra li jinsabu fil- pilloli ta 'Epivir.
Take special care with Epivir Discuss the use of Epivir with your doctor if you have kidney disease.
Oqgħod attent ħafna b’ Epivir Ikkonsulta mat- tabib tiegħek dwar l- użu ta 'l- Epivir jekk għandek xi mard fil- kliewi.
The standard recommended dose of Epivir may have to be reduced.
Id- doża normali rakkomandata għandha mnejn ikollha titnaqqas.
The class of medicines to which Epivir belongs (NRTIs) can cause a condition called lactic acidosis build up of lactic acid in the body), together with an enlarged liver.
Il- klassi ta 'mediċini li Epivir jifforma parti minnha (NRTI) jistgħu jikkawżaw kundizzjoni li tissejjaħ aċidożi lattika (akkumulazzjoni ta ’ aċidu laktiku fil- ġisem), barra minn tkabbir tal- fwied.
Deep rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs mgħaġġel u qawwi, telqa, u sintomi mhux speċifiċi bħal dardir, remettar, u uġigħ fl- istonku, jistgħu jindikaw li qed tiżviluppa l- aċidożi lattika.
While you are being treated with Epivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Meta tkun qed tieħu Epivir, it- tabib tiegħek jeżaminak sew għal xi sinjali li jistgħu juru l- iżvilupp ta 'l - aċidożi lattika.
56 Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
58 Distribuzzjoni mill- ġdid, akkumulazzjoni jew tnaqqis ta 'xaħam tal- ġisem jistgħu iseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kombinata.
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib tiegħek jekk tara xi bidliet fix- xaħam tal - ġisem.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F’ xi pazjenti b’ infezzjoni avvanzata ta ’ l- HIV (AIDS) u storja ta ’ infezzjonijiet opportunistiċi, jistgħu jizviluppaw sintomi u sinjali ta ’ infammazzjoni minn infezzjonijiet ta’ qabel ftit wara li jinbeda t - trattament kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Jitwemmen li dawn is- sintomi jiġru minħabba li s- sistema immunitarja tal - ġisem tmur għall- aħjar u b’ hekk il- ġisem ikun aktar kapaċi jiġġieled l- infezzjonijiet li setgħu kienu hemm qabel mingħajr ma kienu qed jagħtu sintomi ovvji.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinduna b’ xi sintomi ta ’ infezzjoni jekk jogħġbok informa t- tabib tiegħek immedjatament.
Please speak with your doctor if you have a history of liver disease.
Jekk jogħġbok għid lit- tabib jekk għandek passat mediku ta 'xi mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pazjenti b' epatite B jew Ċ kronika li qegħdin jieħdu xi prodotti antiretrovirali huma f' riskju kbir ta 'xi effetti avversi serji fil- fwied li jistgħu iwasslu għall- mewt u jistgħu għalhekk jiġu bżonn testijiet tad- demm biex jimmonitorjaw il- funzjoni tal- fwied.
If you have a chronic hepatitis B infection, you should not stop your treatment with Epivir without instructions from your doctor, as you may have a recurrence of your hepatitis.
Jekk tbati minn xi infezzjoni ta 'epatite B kronika, m' għandekx twaqqaf il- kura b’ Epivir jekk ma jkunx qallek it- tabib, għax tista' terġa 'titfaċċalek l- epatite.
This recurrence may be more severe if you have serious liver disease.
Jekk jiġri dan, il- marda tista ’ tiqliel jekk ikollok xi mard serju tal- fwied.
You will need to take Epivir every day.
Ikollok bżonn tieħu Epivir kuljum.
This medicine helps to control your condition, but it is not a cure for HIV infection.
Din il- mediċina tgħin biex tikkontrolla l- kundizzjoni tiegħek, iżda ma tfejjaqlekx l- infezzjoni ta 'l- HIV.
You may continue to develop other infections and other illnesses associated with HIV disease.
Jista 'jkomplu jaqbduk infezzjonijiet u mard ieħor assoċjat mal - marda HIV.
Do not stop taking your medicine without first talking to your doctor.
Tieqafx tieħu l- mediċina mingħajr ma tkun kellimt lit- tabib.
Treatment with Epivir has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Epivir ma wrietx li tnaqqas ir- riskju li tgħaddi l- infezzjoni HIV lil ħaddieħor b' xi kuntatt sesswali jew b' xi tniġġis mid- demm.
Bone problems:
Problemi fl- għadam:
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li jieħdu t- terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ ostejonekrożi (mewt tas- sustanza ta ’ l- għadma minħabba nuqqas ta ’ ċirkolazzjoni lejn l- għadma).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, il - konsum ta ’ alkoħol, trażżin immunitarju sever, body mass index aktar għoli, fost l- oħrajn, jistgħu ikunu xi wħud mill- fatturi ta ’ riskju biex tiżviluppa din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ ostejonekrożi huma ebusija tal- ġogi, uġigħ (speċjalment tal- koxxa, l- irkoppa u l- ispalla) u diffikulta ’ fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi informa mill- ewwel lit- tabib tiegħek.
Taking other medicines It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself.
Huwa importanti li tgħid lit- tabib tiegħek bil- mediċini kollha li qed tieħu inklużi dawk li tkun xtrajt int stess.
These may affect the action of Epivir, or Epivir may affect their action.
Dawn jistgħu ikollhom effett fuq kif jaħdem Epivir, jew Epivir jista ’ jkollu effett fuqhom.