qanastek/EMEA-V3 huggingface dataset:
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Għandha tingħata attenzjoni meta jingħataw l- analogi nuklejosidi lil pazjenti (partikolarment nisa obeżi) li jbatu minn epatomegalija, epatite jew fatturi oħra ta 'riskji magħrufa għal mard tal- fwied u steatożi epatika (inklużi xi prodotti mediċinali u alkoħol).
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 kura bl- alpha interferon u ribavirin jistgħu jkunu f' riskju speċjali.
Patients at increased risk should be followed closely.
Pazjenti f' riskju għoli għandhom ikunu taħt osservazzjoni stretta.
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Kemm in vivo kif ukoll in vitro deher li l- analogi tan- nukleosidi u tan - nukleotidi jikkaġunaw gradi varjabbli ta ’ ħsara fil- mitokondrija.
There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/ or post-natally to nucleoside analogues.
Kien hemm rapporti ta ’ disfunzjoni tal- mitokondrija fi trabi li huma negattivi għall HIV li kienu esposti fl- utru u/ jew wara t- twelid għall - analogi tan- nukleosidi.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
L- effetti avversi l- aktar komuni li kienu rrapurtati jinkludu disturbi ematoloġiċi (anemija, newtropenja) u disturbi metaboliċi (iperlaktatemja, iperlipejżemja).
These events are often transitory.
Dawn l - effetti sikwit ikunu transitorji.
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Xi mard newroloġiku li deher iktar tard ġie rrapurtat (ipertonja, aċċessjoni, imġiba mhux normali).
Whether the neurological disorders are transient or permanent is currently unknown.
Bħalissa għadu mhux mgħaruf jekk dan il- mard newroloġiku jgħaddix maż- żmien jew huwiex permanenti.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV-negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Kull tarbija esposta fl- utru għall- analogi tan- nukleosidi u tan- nukleotidi, anke trabi li huma negattivi għall- HIV, għandhom jiġu segwiti klinikament u b’ testijiet tal- laboratorju u jridu jiġu investigati kompletament għall- possibilita ’ ta ’ disfunzjoni tal - mitokondrija f’ każ ta ’ sinjali jew sintomi relevanti.
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 nazzjonali 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.
4 Lipodistrofija: It- terapija kombinata antiretrovirali ġiet asoċjata ma 'distribuzzjoni mill- ġdid tax- xaħam tal- ġisem (lipodistrofija) f' pazjenti bl- HIV.
Knowledge about the mechanism is incomplete.
It- tagħrif dwar il- mekkaniżmu mhuwiex biżżejjed.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside 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 4 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.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi tal- lipidi għandhom ikunu maniġġati kif jixraq klinikament (ara taqsima 4. 8).
Immune Reactivation Syndrome:
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 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.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Dawn ir- reazzjonijiet ġew osservati l- aktar spiss fl- ewwel ftit ġimgħat jew xhur mill- bidu tal- CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti jinkludu retinite b’ cytomegalovirus, infezzjonijiet lokali jew mifruxa b’ mycobacterium, u pnewmonja b’ Pneumocvstis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomi ta ’ infjammazzjoni għandhom ikunu evalwati u t- trattament jinbeda fejn hemm bżonn.
If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SPC.
Jekk lamivudine ikunu qed jintuża fl- istess ħin għall- kura ta 'l- HIV u l- HBV, aktar tagħrif dwar l- użu ta ’ lamivudine għal kura ta ’ infezzjoni ta' l- epatite B jinsab fl- SPC ta ’ Zeffix.
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.
Pazjenti bl- epatite kronika B jew C li jkun fuq terapija antiretrovirali kombinata ikunu f' riskju ogħla ta 'avvenimenti avversi serji u li jistgħu ikunu fatali.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Fil- każ li tkun qed tittieħed ukoll terapija antivirali għall- epatite B jew C, jekk jogħġbok ara wkoll it- tagħrif relevanti dwar il- prodott għal dawn il - prodotti mediċinali.
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).
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 tal- kura.
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Għalkemm il- kawża tista ’ tkun minħabba ħafna fatturi, (li jinkludu l- użu ta ’ kortikosterojdi, il- konsum ta ’ alkoħol, trażżin serju fl- immunita ’, body mass index għoli), każijiet ta ’ nekrożi fl- għadam instab li huma partikolarment aktar komuni f’ pazjenti b’ HIVavvanzat u/ jew użu ta ’ terapija antiretrovirali kombinata (CART) fit- tul.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom ifittxu parir mediku jekk iħossu xi uġigħ jew ebusija fil- ġogi jew isibuha diffiċli biex jiċċaqilqu.
Interaction studies have only been performed in adults
Studji fuq interazzjonijiet saru biss fuq il- kbar.
Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently.
Lamivudine jista ’ ma jħallix il- phosphorylation intraċellulari ta ’ zalcitabine issir meta ż- żewġ prodotti mediċinali jintużaw flimkien.
Epivir is therefore not recommended to be used in combination with zalcitabine.
Għaldaqstant Epivir mhuwiex rakkomandat biex jintuża flimkien ma ’ zalcitabine.
Co-administration of lamivudine with intravenous ganciclovir or foscarnet is not recommended.
L- għoti ta ’ lamivudine flimkien ma 'granciclovir jew foscarnet minn ġol- vini mhux rakkomandat.
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance.
Il- probabbilta 'ta' interazzjonijiet metaboliċi hi baxxa minħabba l- metaboliżmu limitat u t- tagħqid mal - proteina fil- plażma u t- tneħħija kważi totali mill- kliewi.
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.
5 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.
However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary (see section 4.2).
Madankollu, sakemm il- pazjent ma jkollux mard tal- kliewi, ma jkunx hemm bżonn ta 'bdil fid- dożaġġ ta ’ lamivudine (ara taqsima 4. 2).
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.
When concomitant administration is warranted, patients should be monitored clinically.
Meta tinħass il- ħtieġa li dawn jingħataw flimkien, il- pazjenti għandhom ikunu monitorjati klinikament.
Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis carinii pneumonia (PCP) and toxoplasmosis should be avoided.
L- għoti ta ’ lamivudine flimkien ma 'dożi qawwija ta co- trimoxazole għall- kura tal- pulmonite Pneumocystis carinii (PCP) u toxoplażmożi għandu jiġi evitat.
5 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 '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.
Prodotti mediċinali oħra (e. ż ranitidine, cimetidine) jitneħħew biss parzjalment b' dan il- mekkaniżmu u ntwera li ma hemmx interazzjonijiet ma ’ lamivudine.
The nucleoside analogues (e. g. didanosine and zalcitabine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.
L- analogi nuklejosidi (e. ż didanosine u zalcitabine) bħal zidovudine, ma jitneħħewx b' dan il- mekkaniżmu u x' aktarx ma jkunx hemm interazzjonijiet ma ’ lamivudine.
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.
Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 5.2).
Zidovudine ma jeffettwax il - farmakokinetiċi ta ’ lamivudine (ara taqsima 5. 2)
PIs) unlikely.
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).
The safety of lamivudine in human pregnancy has not been established.
Is- sigurta` ta ’ lamivudine fit- tqala tal- bniedem ma ġietx stabbilita.
Reproductive studies in animals have not shown evidence of teratogenicity, and showed no effect on male or female fertility.
Studji dwar ir- riproduzzjoni fl- annimali ma wrewx sinjali ta 'teratoġeniċita', u ma wrew ebda effett fuq il- fertilita 'maskili jew femminili.
Lamivudine induces early embryonic death when administered to pregnant rabbits at exposure levels comparable to those achieved in man.
Lamivudine jikkawża l- mewt bikrija embrijonika meta jingħata lil fniek tqal f' livelli ta 'exposure paragunabbli ma' dawk milħuqa fil- bniedem.
In humans, consistent with passive transmission of lamivudine across the placenta, lamivudine concentrations in infant serum at birth were similar to those in maternal and cord serum at delivery.
Fil- bnedmin, konsistentement mat- trasmissjoni passiva ta ’ lamivudine minn ġol- plaċenta, il- konċentrazzjonijiet ta ’ lamivudine fis- serum ta 'trabi fit - twelid kienu l- istess bħal dawk fis- serum ta' l- omm u tal- kurdun waqt it- twelid.
Although animal reproductive studies are not always predictive of the human response, administration is not recommended during the first three months of pregnancy.
Għalkemm studji dwar ir- riproduzzjoni fl- annimali mhux dejjem ibassru dak li jiġri fil- bniedem, l - għoti ta 'din il- mediċina mhux rakkomandat fl- ewwel tlett xhur tat- tqala.
Following oral administration lamivudine was excreted in breast milk at similar concentrations to those found in serum.
Wara li ttieħed mill- ħalq lamivudine ħareġ fil- ħalib tas- sider f' konċentrazzjonijiet simili għal dawk li kien hemm fis- serum.
Since lamivudine and the virus pass into breast milk, it is recommended that mothers taking Epivir do not breast-feed their infants.
Ladarba lamivudine u l- virus jgħaddu għal ġol- ħalib tas- sider, hu rakkomandat li ommijiet li jkunu qed jieħdu Epivir m' għandhomx ireddgħu lit- trabi tagħhom.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Hu rakkomandat li nisa nfettati bl- HIV taħt l- ebda ċirkostanza m' għandhom ireddgħu lit- trabi tagħhom biex ma jgħaddulhomx l- HIV.
The following adverse reactions have been reported during therapy for HIV disease with Epivir.
Ir- reazzjonijiet avversi li ġejjin ġew irrappurtati waqt terapija għall- marda tal- HIV b’ Epivir.
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 mal- kura huma elenkati hawn taħt skond is- sistema tal- ġisem, il- klassi tal- organi 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)..
Blood and lymphatic systems disorders Uncommon:
6 Disturbi tad- demm u tas- sistema limfatika Mhux komuni:
Nervous system disorders Common:
Disturbi tas- sistema nervuża Komuni:
Headache, insomnia Very rare: peripheral neuropathy (or paraesthesia)
Newropatija periferali (jew parasteżja).
6 Gastrointestinal disorders Common:
Disturbi gastro- intestinali Komuni:
Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare:
Dardir, remettar, uġigħ addominali jew spażmi, dijarreja Rari:
Pancreatitis. elevations in serum amylase.
Pankreatite, żjidiet fl- amylase tas- serum.
Transient elevations in liver enzymes (AST, ALT).
Għoli mhux permanenti fil- livelli ta 'l- enzimi tal- fwied (AST, ALT).
Skin and subcutaneous tissue disorders Common:
Disturbi fil- ġilda u fit- tessuti ta ’ taħta Komuni:
Musculoskeletal and connective tissue disorders Common:
Disturbi muskolu- skeltali, tat- tessut konnettivu ta ’ l- għadam Komuni:
Arthralgia, muscle disorders Rare:
Artralġija, disturbi fil- muskoli Rari:
Rhabdomyolysis
Rabdomajalożi
General disorders and administration site conditions Common:
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jittieħed Komuni:
Fatigue, malaise, fever.
Għeja, telqa, deni.
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues (see section 4.4).
Każijiet ta 'aċidożi lattika, kultant fatali, normalment assoċjati ma' epatomegalija severa u steatożi tal - fwied, ġew irrappurtati bl- użu ta 'analogi nuklejosidi (ara taqsima 4. 4)
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).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
It- terapija antiretrovirali kombinata ġiet assoċjata ma 'anormalitajiet metaboliċi bħal ipertrigliċeridimja, iperkolesterolimja, reżistenza għall- insulina, ipergliċemija u iperlaktejtimja (ara taqsima 4. 4).
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 (see section 4.4).
(ara sezzjoni 4. 4)
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.
The frequency of which is unknown (see section 4.4).
Il- frekwenza ta ’ din m’ hijiex magħrufa (ara sezzjoni 4. 4).
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 disponibbli dwar il- konsegwenzi ta 'inġestjoni ta' dożi eċċessivi akuti fil- bniedem hija limitata.
No fatalities occurred, and the patients recovered.
Ma kien hemm l- ebda fatalitajiet, u l- pazjenti fiequ.
No specific signs or symptoms have been identified following such overdose.
Ma ġewx identifikati sinjali jew sintomi speċifiċi wara t- teħid ta 'dożi eċċessivi bħal dawn.
If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
7 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 fil- kura ta 'doża eċċessiva, għalkemm din ma ġietx studjata.
J05AF05.
Grupp farmakoterapewtiku: analogu nukleoside, Kodiċi ATC: J05 AF05.
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
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’ -
Jiġi metabolizzat fiċ- ċelluli għal komponent attiv, lamivudine 5 '- triphosphate.
Its main mode of action is as a chain terminator of viral reverse transcription.
Il- metodu prinċipali ta 'l- azzjoni tiegħu hu li jwawwaf ir- reverse transcription tal- virus.
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.
HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
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).
This variant arises both in vitro and in HIV-1 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.
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.
In vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when they simultaneously acquire resistance to lamivudine.
Studji in vitro jindikaw li iżolati tal- virus reżistenti għal zidovudine jistgħu isiru sensittivi għal zidovudine meta fl- istess ħin jibnu reżistenza għal lamivudine.
The clinical relevance of these findings is not established.
Ir- rilevanza klinika ta ’ dawn is- sejbiet m’ hijiex stabbilita.
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 konklużjoni fil- qasam li ta ’ min joqgħod fuqha.
In any case, initiation of susceptible NRTI’ s should always be preferred to maintenance of lamivudine therapy.
F’ kull ċirkostanza, huwa dejjem preferibbli li jinbdew NRTI suxxettibli milli terapija regolari b' lamivudine.
Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTI’ s are available.
Għaldaqstant, għandha tiġi kkunsidrata terapija regolari b’ lamivudine minkejja li titfaċċa mutazzjoni ta ’ M184V biss fejn l- ebda NRTI attivi oħra ma ’ jkunu disponibbli.
Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Ir- reżistenza inkroċjata li jagħti l- M184V RT hi limitata fil- grupp tal- inibituri nukleosidi ta 'prodotti antiretrovirali.
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.
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 għal 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.
Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Informazzjoni klinika ta 'l- aħħar stadju tindika li lamivudine mgħoti flimkien ma ’ zinovudine jirriżulta fi tnaqqis sinifikanti tar- riskju li l- marda tmur għall- agħar jew li tirriżulta f' mewt.
Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
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.
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).
8 Lamivudine intuża ħafna bħala komponent ta 'terapija kombinata antiretrovirali ma' prodotti oħra antiretrovirali ta 'l- istess klassi (NRTI) jew ta' klassijiet differenti (PI, inibituri ta ’ reverse transcriptase li mhumiex nuklejosidi)
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.
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.
The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Ir- relazzjoni bejn is- suxxettibilta 'in vitro ta' l- HIV għal lamivudine u r- reazzjoni klinika għal terapija b’ lamivudine għadha qed tiġi investigata.
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).
Lamivudine f' doża ta '100 mg kuljum wera wkoll li hu effettiv fil- kura ta' pazjenti adulti li jbatu minn infezzjoni kronika ta 'l- HBV (għad- dettalji ta' l- istudji kliniċi, ara t- tagħrif għall- preskrizzjoni ta ’ Zeffix).
8 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 (300mg darba kuljum): studju kliniku wera in- nuqqas ta ’ inferjorita ’ bejn sistemi ta ’ kura b’ 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 inkisbu f’ popolazzjoni mingħajr esperjenza ta ’ kura antiretrovirali, li tikkonsisti primarjament minn pazjenti infettati bl- HIV mingħajr sintomi (CDC stadju A).
Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
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%.
Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Wara li jittieħed mill - ħalq, il- ħin medju (tmax) biex jintlaħqu konċentrazzjonijiet massimi fis- serum (Cmax) hu ta 'madwar siegħa.
Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150mg 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.
Bbażat fuq informazzjoni miksuba minn studju li sar fuq voluntieri f' saħħithom, f' 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.
The mean (CV) AUC over a dosing interval of 12 hours is 4.7 µg. h/ ml (18%).
Il- medja (CV) AUC matul intervall fid- dożi ta '12- il siegħa hi 4. 7 µg. h/ ml (18%).
At a therapeutic dose of 300mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ ml (26%), 0.04 µg/ ml (34%) and 8.9 µg. h/ ml (21%), respectively.
B' doża terapewtika ta '300 mg kuljum, Cmax medju, Cmin medju fi stat stabbli u 24h AUC f’ 24 siegħa huma 2. 0 µg/ ml (26%), 0. 04 µg/ ml (34%) u 8. 9 µg. h/ ml (21%), rispettivament.
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%).
However, the extent (based on the AUC) of lamivudine absorbed is not influenced.
Madankollu, il- kwantita '(ibbażata fuq l- AUC) ta ’ lamivudine li tiġi assorbita ma tkunx affettwata.
This conclusion is based on the physiochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Din il - konklużjuni hija bbażata fuq id- data fiżikokimika u farmakokinetika meta wieħed jassumi li l- pazjent ifarrak u jittrassferixxi 100% tal- pillola u jeħodha minnufih.
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.
This is not considered to be of significance to patient safety and therefore no dosage adjustments are necessary.
Dan mhux meqjus ta 'importanza għas- sigurta' tal- pazjent u għalhekk ma jkunx hemm il- ħtieġa ta 'tibdil fid- dożaġġ.
From intravenous studies, the mean volume of distribution is 1.3 l/ kg.
Minn studji dwar it- teħid minn ġol- vini jirriżulta li l- volum medju ta 'distribuzzjoni hu 1. 3 l/ kg.
The observed half-life of elimination is 5 to 7 hours.
Il- half- life ta ’ eliminazzjoni osservata dwar it- teħid minn ġol- vini hi ta 'bejn 5 u 7 sigħat.
The mean systemic clearance of lamivudine is approximately 0.32 l/ h/ kg, with predominantly renal clearance (> 70%) via the organic cationic transport system.
Il - medja tat- tneħħija sistemika ta ’ lamivudine hi madwar 0. 32 l/ h/ kg, bi tneħħija predomonanti mill - kliewi (> 70%) permezz tas- sistema tat- trasport organika u katajonika.
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).
(< 16% - 36% għall- albumin tas- serum fi studji in vitro).
Limited data show that lamivudine penetrates the central nervous system and reaches the cerebro- spinal fluid (CSF).
9 Informazzjoni limitata turu li lamivudine jidħol fis- sistema nervuża ċentrali u jilħaq il- fluwidu ċerebro- spinali (CSF).
The mean ratio CSF/ serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Il - proporzjon medju ta ’ CSF/ konċentrazzjoni ta ’ lamivudine fis- serum 2- 4 sigħat wara t- teħid mill- ħalq kienet ta 'madwar 0. 12.
The true extent of penetration or relationship with any clinical efficacy is unknown.
Kemm verament jippenetra jew ir- relazzjoni ma 'l- effikaċja klinika mhux magħrufa.
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).
Il - komponent attiv ta ’ lamivudine triphosphate fiċ- ċelluli għandu half- life terminali imtawwla fiċ- ċellula (16 sa 19- il siegħa) meta mqabbel mal- half- life fil- plażma (5 sa 7 sigħat).
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.
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 fiċ- ċelluli AUC24 u Cmax.
Lamivudine is predominately cleared unchanged by renal excretion.
Il- biċċa l- kbira ta ’ lamivudine jitneħħa mill- ġisem mingħajr ma jinbidel permezz ta ’ sekrezzjoni mill - kliewi.
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.
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 tal - plażma huwa baxx.
9 Elimination:
Tneħħija:
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Studji li saru f' pazjenti b’ indeboliment tal- kliewi juru li t- tneħħija ta ’ lamivudine mill- ġisem tiġi affettwata meta l- kliewi ma jaħdmux tajjeb.
A recommended dosage regimen for patients with creatinine clearance below 50 ml/ min is shown in the dosage section (see section 4.2).
Dożaġġ rakkomandat għal pazjenti bi tneħħija tal - krejatinina inqas minn 50 ml/ min jidher fit- taqsima dwar dożaġġ (ara taqsima 4. 2).
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% 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.
This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
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).
Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
L- għoti ta ’ co- trimoxazole ma ’ lamivudine lil pazjenti b’ indeboliment tal- kliewi għandu jitqies b' attenzjoni kbira.
Pharmacokinetics in children:
Farmakokinetiċi fit- tfal:
In general, lamivudine pharmacokinetics in paediatric patients is similar to adults.
B’ mod ġenerali, il- farmakokinetiċi ta ’ lamivudine f' pazjenti pedjatriċi huma l- istess bħal ta 'l- adulti.
However, absolute bioavailability (approximately 55-65%) was reduced in paediatric patients below 12 years of age.
Madankollu, il- biodisponibilita 'assoluta (madwar 55- 65%) kienet inqas f' pazjenti pedjatriċi ta ’ taħt it- 12- il sena.
In addition, systemic clearance values were greater in younger paediatric patients and decreased with age, approaching adult values around 12 years of age.
Barra minn hekk, il- valuri ta 'tneħħija mill- ġisem kienu akbar fi tfal ta' eta 'aktar żgħira u bdew jonqsu aktar ma tikber l- eta', sakemm laħqu l- valuri ta 'l- adulti fl- eta' ta '12- il sena.
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 rakkomandata ta ’ lamivudine fit- tfal (ta 'aktar minn tlett xhur u li jiżnu anqas minn 30kg) hi ta' 4 mg/ kg / darbtejn kuljum.
This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng. h/ ml.
Din id- doża tikseb AUC0- 12 medja minn bejn wieħed u ieħor 3, 800 sa 5, 300 ng. h/ ml.
Recent findings indicate that exposure in children < 6 years of age may be reduced by about 30% compared with other age groups.
Sejbiet riċenti juru li l- espożizzjoni fi tfal ta ’ < 6 snin tista 'titnaqqas b’ xi 30% meta mqabbla ma' gruppi oħra.
Further data addressing this issue are currently awaited.
Bħalissa hija mistennija aktar informazzjoni li tindirizza dan.
At present, the available data do not suggest that lamivudine is less efficacious in this age group.
Informazzjoni disponibbli bħalissa ma tissuġġerix li lamivudine huwa anqas effikaċi f’ din l- eta '.
There are limited pharmacokinetic data for patients less than three months of age.
Hemm informazzjoni limitata dwar il- farmakokinetiċi għal pazjenti ta 'inqas minn tlett xhur.
In neonates one week of age, lamivudine oral clearance was reduced when compared to paediatric patients and is likely to be due to immature renal function and variable absorption.
Fi trabi ta 'ġimgħa, it- tneħħija ta ’ lamivudine orali naqset meta mqabbla ma' pazjenti pedjatriċi u dan aktarx minħabba li l- kliewi jkunu għadhom ma bdewx jaħdmu biżżejjed u minħabba li l- assorbiment ivarja.
Therefore to achieve similar adult and paediatric exposure, the recommended dose for neonates is 4 mg/ kg/ day.
Għalhekk biex tinkiseb espożizzjoni simili fl - adulti u fit- tfal, id- doża rakkomandata għal trabi tat - twelid hi ta '4 mg/ kg/ kuljum.
Glomerular filtration estimates suggests that to achieve similar adult and paediatric exposure, the recommended dose for children aged six weeks and older could be 8 mg/ kg/ day.
Stimi ta 'filtrazzjoni gromerulari jindikaw li biex tinkiseb espożizzjoni simili fl- adulti u fit- tfal, id- doża rakkomandata għal tfal ta' sitt ġimgħat u aktar tista 'tkun ta' 8 mg/ kg/ kuljum.
Pharmacokinetics in pregnancy:
Farmakokinetiċi fit- tqala:
Following oral administration, lamivudine pharmacokinetics in late- pregnancy were similar to non-pregnant women.
Wara t- teħid mill- ħalq, il- farmakokinetiċi ta ’ lamivudine fi tqala avvanzata kienu simili għal dawk ta 'nisa mhux tqal.
Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
L- għoti ta ’ 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 fl- indikaturi tal- funzjoni tal- fwied u tal- 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 taċ- 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 kienx
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
10 ġenotossiku in vivo f' dożi li pproduċew konċentrazzjonijiet fil- plażma ta 'madwar 40- 50 darba aktar mill- livelli kliniċi fil- 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 l- kura.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
Studju transplaċentali ġenotossiku li sar fix- xadini qabbel zidovudine waħdu mat- taħlita ta 'zidovudine u lamivudine f' espożizzjonijiet ekwivalenti fil- bniedem.
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 clinical significance of these findings is unknown.
Ma hijiex magħrufa l- importanza klinika ta ’ dawn is- sejbiet.
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans.
Ir- riżultati ta 'studji fit- tul dwar il- karċinoġeniċita ’ fuq firien u ġrieden ma wrew l- ebda potenzjal karċinoġeniku relevanti għall- bniedem.
10 Tablet core:
Il- qalba tal- pillola:
Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
Microcrystalline cellulose Sodium starch glycollate Magnesium Stearate
Tablet film-coat:
Ir- rita tal- pillola:
Hypromellose (E464) Titanium dioxide (E171), Macrogol, Polysorbate 80
Hypromellose (E464) Macrogol Polysorbate 80
6.2 Incompatibilities
Inkompatibilitajiet 6. 2
Not applicable.
Ma jgħoddx f' dan il- każ
HDPE bottles:
Fliexken HDPE:
PVC/ aluminium foil blister packs:
Pakketti b' folji ta 'PVC/ aluminju:
2 years
sentejn
Do not store above 30°C
Taħżnux f' temperatura ‘ l fuq minn 30°C
Child resistant HDPE bottles or PVC/ aluminium foil blister packs each containing 60 tablets.
FFliexken HDPE li ma jinfetħux mit- tfal jew f' pakketti b' folji tal- PVC/ aluminju li jkun fihom 60 pillola kull wieħed.
MARKETING AUTHORISATION HOLDER
11 7 ID- DETENTUR TA 'L- AWTORIZZAZJONI GĦAT- TQEGĦID FIS- SUQ
8.
8 NUMRU TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER
EU/ 1/ 96/ 015/ 001 (Flixkun)
EU/ 1/ 96/ 015/ 001 (Bottle) EU/ 1/ 96/ 015/ 004 (Blister pack)
EU/ 1/ 96/ 015/ 004 (Pakkett bil- folji)
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
9 DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI
8 August 1996 Date of last renewal:
8 ta' Awwissu 1996 Data ta ’ l- aħħar tiġdid:
28 July 2006
28 ta ’ Lulju 2006
DATE OF REVISION OF THE TEXT
10 DATA TA 'META ĠIET RIVEDUTA L- KITBA
11 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
NAME OF THE MEDICINAL PRODUCT
12 ISEM TAL- PRODOTT MEDIĊINALI
Epivir 10 mg/ ml oral solution
Epivir 10 mg/ ml soluzzjonili li tittieħed mill- ħalq
Each ml of oral solution contains 10 mg of lamivudine.
Kull ml ta ’ soluzzjoni li tittieħed mill- ħalq fiha 10 mg ta 'lamivudine.
Sucrose 20% (3 g/ 15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate
Sucrose 20% (3g/ 15ml) Methyl parahydoxybenzoate Propyl parahydroxybenzoate
Oral solution
Soluzzjoni li tittieħed mill- ħalq
Clear, colourless to pale yellow solution.
Soluzzjoni ċara, bla kulur jew tagħti fl- isfar
Adults and adolescents over 12 years of age: the recommended dose of Epivir is 300 mg daily.
Adulti u adolexxenti 'l fuq minn 12- il sena: id- doża rakkomandata ta' Epivir hi ta '300 mg kuljum.
This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4).
Din tista tingħata jew 150 mg (15ml) darbtejn kuljum jew 300 mg (30ml) darba kuljum (ara taqsima 4. 4).
Patients changing to the once daily regimen should take 150 mg (15 ml) twice a day and switch to 300 mg (30 ml) once a day the following morning.
Pazjenti li jaqilbu għall- kura ta 'darba kuljum għandhom jieħdu 150 mg (15ml) darbtejn f’ ġurnata u jaqilbu għal 300 mg (30ml) darba kuljum l- għada filgħodu.
Where an evening once daily regimen is preferred, 150 mg (15 ml) of Epivir should be taken on the first morning only, followed by 300 mg (30 ml) in the evening.
Epivir fl- ewwel għodwa biss, imbagħad 300 mg (30ml) filgħaxija.
When changing back to a twice daily regimen, patients should complete the days treatment and start 150 mg (15 ml) twice a day the following morning.
Meta pazjenti jerġgħu lura għall- kura ta 'darbtejn kuljum dawn għandhom ikomplu l- kura tal- ġurnata imbagħad jibdew jieħdu 150 mg (15ml) kuljum mill- għada filgħodu.
Children
Tfal:
Three months to 12 years of age: the recommended dose is 4 mg/ kg twice daily up to a maximum of 300 mg daily.
Minn tlett xhur sa tnax- il sena: id- doża rakkomandata hi ta '4 mg/ kg darbtejn kuljum sa massimu ta' 300 mg kuljum.
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).
Epivir is also available as a tablet formulation.
Epivir huwa wkoll disponibbli f' għamla ta 'pilloli
Epivir may be administered with or without food.
Epivir jista jingħata ma 'l- ikel jew fuq stonku vojt.
13 Renal impairment:
13 Indeboliment tal- kliewi: - Il- konċentrazzjonijiet ta ’ lamivudine jiżdiedu f' pazjenti b' indeboliment moderat jew sever tal- kliewi minħabba nuqqas ta 'tneħħija mill- ġisem.
The dose should therefore be adjusted (see tables).
Id- doża għandha, għalhekk tinbidel, għal soluzzjoni orali ta 'Epivir f' pazjenti li t- tneħħija ta' krejatinina tagħhom tinżel għal inqas minn 30 ml/ min (ara t- tabelli).
Dosing recommendations – Adults and adolescents over 12 years:
Rakkomandazzjonijiet dwar id- dożi - Adulti u adolexxenti 'l fuq minn 12- il sena:
150 mg (15 ml) 150 mg (15 ml) 150 mg (15 ml) 150 mg (15 ml) 50 mg (5 ml)
150 mg (15ml) 150 mg (15ml) 150 mg (15ml) 150 mg (15ml) 50mg (5m)
150 mg (15 ml) twice daily 150 mg (15 ml) once daily 100 mg (10 ml) once daily 50 mg (5 ml) once daily 25 mg (2.5 ml) once daily
150 mg (15ml) darbtejn kuljum 150 mg (15ml) darba kuljum 100mg (10ml) darba kuljum 50mg (5ml) darba kuljum 25mg (2. 5ml) darba kuljum
Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults.
Fuq is- suppożizzjoni li t- tneħħija ta 'krejatinina u t- tneħħija ta ’ lamivudine huma korrelatati l- istess fit- tfal u fl- adulti hu rakkomandat li d- dożaġġ fi tfal b' indeboliment tal- kliewi għandu jitnaqqas skond it - tneħħija krejatinina bl- istess proporzjon bħal fil- każ ta' l- adulti..
Dosing recommendations – Children from 3 months to 12 years:
Rakkomandazzjonijiet dwar id dożi - Tfal minn 3 xhur sa 12- il sena:
In patients with moderate – to- severe renal impairment, the terminal plasma half- life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see section 4.2).
F' pazjenti b' indeboliment tal- kliewi moderat jew sever, il- half- life terminali ta ’ lamivudine fil- plażma tiżdied minħabba tnaqqis fit- tneħħija mill- ġisem, għalhekk id- doża trid tinbidel (ara taqsima 4. 2).